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2022 FDA Drug Approvals | US Pharma News | iPharmaCenter

Updated: Jun 26, 2023


 

December 23, 2022

FDA approved Lunsumio, Roche's bispecific antibody, for follicular lymphoma

Roche announced that its bispecific antibody Lunsumio (mosunetuzumab) was approved for treating relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

The approval was based on the pivotal phase II GO29781; an open-label dose-escalation study aimed to evaluate Lunsumio in patients with relapsed or refractory B-cell non-Hidgkin lymphoma. In patients who received at least two previous treatments, 80% achieved durable response rates, with 60% achieving complete remission.

Lunsumio has received accelerated approval based on the response rate. Complete approval will be based on the clinical benefit demonstrated in the confirmatory trial. Lunsumio is a CD20xCD3 T-cell engaging bi-specific antibody administered in fixed duration for cancers.


Follicular lymphoma is a common slow-growing cancer, a form of non-Hodgkin lymphoma. In 2022, in the US, nearly 13,000 new cases of follicular lymphoma were diagnosed.

 

December 22, 2022

Gilead received approval for its twice-yearly HIV treatment Sunlenca.

Gilead announced that the US Food and Drug Administration approved Sunlenca (lenacapavir), a twice-yearly treatment for treating multi-drug resistant human immunodeficiency virus infection.

Sunlenca is a capsid inhibitor, given in combination with other antivirals (ARV), and is approved for heavily treatment-experienced HIV patients. There is no cross-resistance reported with existing classes of HIV therapies.


The approval was based on the Phase 2/3 CAPELLA trial, in which Sunlenca was tested in combination with a background regimen. At week 52, 83% of patients administered Sunlenca plus background therapy achieved an undetectable viral load.

Sunlenca received Breakthrough Therapy Designation for treating HIV-1 infection.

 

November 17, 2022

Tzield approved for delaying Stage 3 T1D in adults and pediatrics with Stage 2 T1D

Provention Bio announced that Tzield (teplizumab) was approved for delaying progression to Stage 3 type-1 diabetes (T1D) in adults and pediatrics of age eight years and older with Stage 2 type-1 diabetes (T1D). Tzield prevented the progression to stage 3 T1D by twenty-five months versus placebo.

Tzield is an anti-CD3-directed antibody for intravenous use and is the first immunomodulatory agent approved for preventing the progression of stage 2 diabetes.

The approval was based on a double-blind, placebo-controlled trial in patients with stage 2 type 1 diabetes. Tzield was administered via intravenous infusion for 14 days; the primary endpoint is the time from randomization to progression to stage 3 type 1 diabetes. After 51 months, 45% of patients on Tzield were diagnosed with stage 3 type 1 diabetes versus 72% of patients who received a placebo. There was a statistically significant difference between Tzield versus placebo.

The common adverse events are decreased levels of white blood cells, rash, and headache.

Patients who progress to stage 3 T1D require insulin for life, and stage 3 T1D might lead to diabetic ketoacidosis.



 

November 11, 2022

Imfinzi, Imjudo plus chemotherapy was approved for NSCLC in the US.

AstraZeneca announced that the US Food and Drug Administration approved Imfinzi (durvalumab), Imjudo (tremelimumab), plus chemotherapy combination for patients with Stave IV non-small cell lung cancer.

The approval was based on the POSEIDON Phase III trial; a global open-label study aimed to determine the efficacy of Imfinzi (durvalumab), Imjudo (tremelimumab), plus chemotherapy versus chemotherapy in the first-line setting in patients with metastatic non-small cell lung cancer.

Imfinzi plus five cycles of Imjudo plus four cycles of chemotherapy reduced the risk of death by 23% versus chemotherapy. 33% of patients on the Imfinzi combination were alive after two years versus 22% of patients on chemotherapy. The combination reduced the risk of disease progression by 28% versus chemotherapy. 25% of patients on combination were alive after three years versus 13.6% on chemotherapy.

In the US, lung cancer is the second most common cancer; it was estimated that nearly 236,000 patients would be diagnosed with it in 2022. Only 8% of patients are alive after five years of diagnosis because of the poor prognosis.

 

October 25, 2022

The US FDA approved Tecvayli for multiple myeloma.

Janssen Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli (teclistamab) for adult patients with refractory multiple myeloma. The drug is approved for patients previously treated with four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

Tecvayli received accelerated approval based on response rate, and complete approval will be received upon verification of efficacy with confirmatory trials.

The accelerated approval was based on the Phase 2 MajesTEC-1 clinical trial, which recruited 110 patients treated with a median of five lines of therapy. Nearly 78% of patients were previously treated with four lines of treatment. The overall response rate (ORR) was 61.8%, and 28.2% showed a complete response. The median time for response was 1.2 months. At six months, the duration of response was 90.6%, and 66.5% at nine months.

Tecvayli is a bispecific T-cell engager antibody available in the subcutaneous form.

 

October 21, 2022

Rinvoq approved for non-radiographic axial spondyloarthritis, sixth indication approval in the US.

Rinvoq (upadacitinib) was approved for adults with active non-radiographic axial spondyloarthritis (nr-axSpA). Rinvoq is the first and only JAK inhibitor approved for nr-axSpA.

The approval was based on the Phase 3 SELECT-AXIS 2 trial, in which 44.9% of patients on Rinvoq achieved ASAS40 compared to 22.3% of patients on placebo at week 14. The efficacy was observed as early as the second week of the initiation of treatment.

Rinvoq can cause some severe adverse events. It might lead to severe infection by reducing the body's ability to fight infection; some might be fatal because of infections by tuberculosis (TB), bacteria, fungi, or viruses. It increases the death risk in patients 50 years and older with one or more heart disease risk factors. Further, it can increase the risk of cancers, including lymphoma and skin cancer. Patients with at least one risk factor of heart disease have increased chances of heart attack, stroke, and death. It also increases the chances of blood clots in these patients. It might also cause tears in the stomach or intestines.

 

October 12, 2022

FDA authorized the use of Pfizer and Moderna Bivalent COVID-19 vaccines as a booster dose for children down to five years.

The US Food and Drug Administration has authorized the use of Moderna and Pfizer COVID-19 vaccines as a booster dose in children who received primary vaccination. The Moderna COVID-19 vaccine is administered as a booster dose in children down to six years of age. Pfizer's COVID-19 vaccine is authorized for children down to five years of age.


The bivalent vaccine has an mRNA component of the original strain which is common between omicron variant BA.4 and BA.5. The vaccine is protective against the COVID-19 virus. The mRNA stimulates the host cells to make spike proteins identical in BA.4 and BA.5.


The monovalent Pfizer-BioNTech COVID-19 vaccine is now not authorized as a booster dose for children between the age of five to eleven years. The Moderna and Pfizer vaccines are authorized for primary vaccination in individuals six months and older.


 

October 07, 2022

US FDA approved Boostrix during pregnancy for preventing whooping cough in infants.

The United States Food and Drug Administration (FDA) approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed) in pregnant women for preventing whooping cough (pertussis) in infants younger than two months. Boostrix has to administer in the third trimester of pregnancy.


The approval was based on the observational case-control study, and FDA found the real-world evidence appropriate for the approval. Boostrix was 78% effective in preventing whopping cough when administered during the third trimester of pregnancy.

The safety of Boostrix in the third trimester of pregnancy was assessed based on a randomized, placebo-controlled study in the ex-US population. It was observed to be safe, and FDA stated that since the formulation is the same, it was believed to be safe in the US population as the formulation contains the same components, except the percentage of aluminum is higher in the non-US formulation. There were no vaccine-related adverse events during pregnancy or in infants.


Pertussis is a respiratory illness that often has severe implications in babies. It was considered a common outbreak in the US. Hospitalizations and deaths are reported in infants younger than two months of age, and with the Boostrix vaccine, these infants get protected. Nearly 4.2% of pertussis cases in the US are reported in infants six months and younger, out of which almost 31% require hospitalization.


 

September 21, 2022

Retevmo was approved for adults with advanced or metastatic RET-positive solid tumors.

The US Food and Drug Administration approved Lilly's Retevmo (selpercatinib, 40 mg & 80 mg capsules) for rearranged during transfection (RET) gene fusion advanced or metastatic solid tumors. Retevmo was authorized for solid tumors under accelerated approval and was based on the overall response rate and duration of response. The continued approval will be based on the clinical benefit demonstrated in the confirmatory trial.


The approval was based on the LIBRETTO-001 trial, in which the overall response rate was 44%, and the median duration of response was 24.5 months.

Retevmo was previously approved for RET fusion-positive non-small cell lung cancer (NSCLC), and RET-mutant medullary thyroid cancer (MTC).


 

August 12, 2022

FDA approved Xofluza to treat influenza in children

Roche announced that Xofluza (baloxavir marboxil) was approved by the U.S. Food and Drug Administration for treating influenza in children of 5 years and older. It is also approved for preventing influenza in children of five to twelve years old who came in contact with the influenza-infected individual.


The approval was based on two Phase 3 trials - miniSTONE-2 and BLOCKSTONE. In the miniSTONE-2 trial, the median time to alleviate sign symptoms was 138 months and 150 months in patients who received Xofluza or oseltamivir, respectively. In the BLOCKSTONE study, treating with Xofluza significantly reduced the risk of developing the infection by 90% versus placebo in individuals who came in contact with influenza-infected patients.

Xofluza is administered orally for uncomplicated acute influenza and acts by inhibiting cap-dependent endonuclease protein, a vital protein for virus replication.


 

August 10, 2022

FDA approved Bayer's Nubeqa for mHSPC

The U.S. Food and Drug Administration (FDA) approved Bayer's Nubeqa (darolutamide) plus docetaxel combination for treating men with metastatic hormone-sensitive prostate cancer (mHSPC).

The approval was based on the Phase III ARASENS trial, intended to compare darolutamide versus placebo. Overall survival was considered the primary endpoint. The risk of death was reduced by 32.5% in patients when administered with darolutamide plus androgen deprivation therapy (ADT) and docetaxel.

Prostate cancer is the second most prevalent cancer in the world. Nearly 375,000 deaths are reported every year because of prostate cancer.

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June 17, 2022

Skyrizi received FDA approval for Crohn's Disease for adults.

AbbVie has announced that the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) for adults with moderate to severe Crohn's disease. This was the third indication approved for Skyrizi in the U.S.; previously, it was approved for psoriasis and psoriatic arthritis in adults.


AbbVie announced that Skyrizi showed improvement in endoscopic response and clinical remission versus placebo, both as an induction and maintenance therapy.

ADVANCE and MOTIVATE are the induction studies that showed improvement in endoscopic and clinical outcomes. At 12 weeks, a significant percentage of patients achieved endoscopic response and clinical remission versus placebo.

FORTIFY, a 52-week maintenance trial, patients, achieved endoscopic response and clinical remission versus placebo after a year.


 

May 20, 2022

FDA approved Dupixent for patients with eosinophilic esophagitis

Sanofi announced that the US FDA approved Dupixent (dupilumab) for 12 years and older patients with eosinophilic esophagitis. Dupixent is the first treatment approved in the US for eosinophilic esophagitis.

The approval was based on the Phase 3 trial, which includes two parts (Part A and Part B), which evaluated Dupixent 300 mg weekly compared to placebo. After 24 weeks of treatment with Dupixent 300 mg, the changes in Part A and Part B were:

  • 69% and 64% of patients had disease symptoms reduction compared to 32% and 41% in patients on placebo

  • 60% and 59% of patients achieved histological disease remission compared to 5% and 6% in patients on placebo

  • The safety profile of Dupixent was consistent with the other indications


FDA evaluated Dupixent under Priority Review. Sanofi announced that the European Medicines Agency is reviewing the submission, and submission to other regulatory agencies is expected by the end of 2022.


 

May 05, 2022

Enhertu is approved in the US for HER2-positive metastatic breast cancer.

AstraZeneca and Daiichi Sankyo announced that Enhertu (trastuzumab deruxtecan) was approved for adult patients with unresectable or metastatic HER2-positive breast cancer who were previously treated with the anti-HER2-based regimen.

The approval was based on the DESTINY-Breast03 Phase III trial, a head-to-head, open-label, randomized study comparing Enhertu (5.4mg/kg) versus T-DM1. The study was conducted in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. Enhertu (trastuzumab deruxtecan) reduced the risk of death or disease progression by 72% versus trastuzumab emtansine.

 

April 29, 2022

FDA approved Rinvoq for ankylosing spondylitis

FDA approved Rinvoq (upadacitinib) for treating adults with ankylosing spondylitis. The dosage was 15 mg once daily. Rinvoq is approved for patients who have had an inadequate response or intolerance to one or more anti-TNF inhibitors.

The approval was based on the Phase 3 SELECT-AXIS 2 and the Phase 2/3 SELECT-AXIS 1 trials; SELECT-AXIS 2 included patients who were intolerant or had an inadequate response to two or more biologic disease-modifying anti-rheumatic drugs, and SELECT-AXIS 1 included patients who were biologic naive and were having inadequate response or intolerant to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).


In both trials, ASAS40 response at week 14 was considered the primary endpoint.


The trial demonstrated a significant improvement in back pain, improvements in physical function, and disease activity compared to placebo at week 14.

Rinvoq adverse events are:

  • Rinvoq reduces the ability to fight infections; some might cause morality because of TB, virus, and bacterial infections

  • Increase risk of death in 50+ years older with one or more heart disease risk factors

  • Increases the risk of cancer, including skin cancer and lymphoma

  • Increase in the risk of cardiovascular risks, including heart attack, stroke, or death in people 50 years

  • Causes blood clots, some of which are fatal

  • Tears in the stomach and intestines

  • Causes severe allergy

 

April 28, 2022

BMS Camzyos was approved for treating adult patients with symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM)

BMS announced that the US Food and Drug Administration approved Camzyos (mavacamten) for treating adult patients with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. BMS announced that Camzyos targets cardiac myosin, which is involved in the pathophysiology of obstructive HCM.

Camzyos might cause heart failure because of the reduction in left ventricular ejection fraction (LVEF), and the drug is not recommended in patients with LVEF <55%. It was recommended to have echocardiogram assessments of LVEF during the treatment period.


BMS provided Phase 3 EXPLORER-HCM trial results for approval. 73% of patients have NYHA class II, and 27% of patients with NYHA class III were included in the trial. At thirty weeks of treatment, 37% of patients achieved the primary endpoint (improvement of mixed venous oxygen tension (pVO2) by ≥1.5 mL/kg/min, improvement in NYHA class by at least one or improvement of pVO2 by ≥3.0 mL/kg/min, and without worsening in NYHA class) compared to 17% in patients on placebo. The most common adverse events were dizziness and syncope.

Camzyos is anticipated to generate peak sales of $4 billion.

 

Apr 06, 2022

Novartis' Vijoice is approved in the US for treating PIK3CA-Related Overgrowth Spectrum (PROS)

Novartis announced that Vijoice (alpelisib) was approved for treating severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS). It is indicated in patients for adults and pediatric patients two years of age and older. It is the first approved product for PROS, which is characterized by overgrowths and blood vessel anomalies.

The approval is based on real-world evidence EPIK-P1. At week 24, 27% of patients achieved response (20% or more significant reduction in the sum of PROS target lesion volume). During primary analysis, no patients showed disease progression.




April 01, 2022

FDA approved Gilead's Yescarta for treating patients with relapsed or refractory large B-cell lymphoma

Gilead announced that the U.S. Food and Drug Administration (FDA) approved Yescarta (axicabtagene ciloleucel) for treating adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy.

The approval is based on the ZUMA-7 trial. After treatment with Yescarta, there was a significant improvement in the event-free survival compared to the standard of care. After two years of treatment, 40.5% of patients treated with Yescarta were alive without disease progression or requiring new treatments compared to 16.3% of patients on standard of care. Event-free survival was 8.3 months in the Yescarta arm compared to 2.0 months in the standard of care.



Mar 23, 2022

Novartis Pluvicto is approved in the US for treating PSMA positive metastatic castration-resistant prostate cancer

Novartis has announced that the US FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for treating adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer. The drug is indicated in patients who were previously treated with androgen receptor inhibitors and taxanes-based chemotherapy.


Pluvicto is the first radioligand therapy (RLT) approved by the US FDA, and Novartis submitted an application for approval in Europe.

The approval is based on the Phase III VISION trial. The patient population was treated with PSMA-positive mCRPC patients previously treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Patients who were treated with Pluvicto plus standard of care showed improvement in the overall survival compared to standard of care alone. Pluvicto reduced the reduction in death by 38% and the risk of radiographic progress or death compared to SoC alone. The overall responses in Pluvicto plus SoC were 30 versus 2% in SoC alone arm.



Jan 31, 2022

FDA approved Moderna's COVID-19 Vaccine

The FDA announced that it had approved Moderna's COVID-19 vaccine, Spikevax, to prevent the COVID19 infection in individuals 18 years and older.

The vaccine is in use under the Emergency Use Authorization and is administered in two doses. The vaccine is effective in preventing disease in 93% of individuals. The vaccine is effective in preventing severe infection in 98% of individuals.



Jan 31, 2022

Roche’s Vabysmo approved in the US for nAMD and DME

Roche has announced that Vabysmo (faricimab) was approved for treating neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The drug acts by inhibiting

  • neutralizing angiopoietin-2 (Ang-2)

  • vascular endothelial growth factor-A (VEGF-A)

The approval is based on four phase III studies in nAMD and DME. Across all the studies, Vabysmo showed non-inferiority versus aflibercept when administered every four months.


In, TENAYA and LUCERNE Studies, Roche compared Vabysmo versus aflibercept. The primary endpoint is the average change in the best-corrected visual acuity (BCVA) score. In TENAYA and LUCERNE Studies, the improvement in vision gain is +5.8 and +6.6 letters versus +5.1 and +6.6 letters in the aflibercept arm.


In YOSEMITE and RHINE Studies, the efficacy of Vabysmo compared with aflibercept in patients with diabetic macular edema. The primary endpoint is the average change in the BCVA score.

In the YOSEMITE trial, the change in the baseline in different arms are

  • Vabysmo treat and extend arm: +11.6

  • Vabysmo two-months arms: +10.7

  • Aflibercept arm: +10.9

In the RHINE trial, the change in the baseline in different arms are

  • Vabysmo treat and extend arm: +10.8

  • Vabysmo two-months arms: +11.8

  • Aflibercept arm: +10.3




Jan 21, 2022

US FDA approved Skyrizi for psoriatic arthritis

AbbVie announced that Skyrizi (risankizumab) is approved for treating adults with psoriatic arthritis.

Skyrizi has met the primary endpoint of ACR20 in two pivotal studies. There was an improvement in joint symptoms versus placebo. Skyrizi has to be administered four times a year during maintenance.


The approval is based on KEEPsAKE-1 and KEEPsAKE-2

KEEPsAKE-1L - 57.3% vs 33.45%

KEEPsAKE-2: 51.3% vs 26.5%

Skyrizi has improved dactylitis and enthesitis in patients with psoriatic arthritis versus placebo.



Jan 14, 2022

US FDA approved Pfizer's Cibinqo and Rinvoq for patients with moderate-to-severe atopic dermatitis.

Both Cibinqo and Rinvoq are JAK inhibitors.

Cibinqo approved for moderate-to-severe atopic dermatitis

Pfizer has announced that the US FDA approved Cibinqo (abrocitinib) for treating adult patients with refractory, moderate-to-severe atopic dermatitis, who were previously treated with systemic therapy, including biologics.

Cibinqo is available in three doses: 100 mg and 200 mg. 200 mg is recommended in patients who do not respond to 100 mg. Also, 50 mg is approved for patients with renal impairment and receiving inhibitors of cytochrome P450 (CYP) 2C19.

The approval is based on the following trials:

  • JADE MONO-1, JADE MONO-2, and JADE COMPARE: A double-blind placebo-controlled trials which evaluated the efficacy and safety of 100 and 200 mg of Cibinqo. The primary endpoint is Investigator Global Assessment (IGA) and Eczema Area and Severity Index -75 (EASI) responses after 12 weeks of treatment.

  • JADE MONO-1

    • IGA response: 24%, 44%, and 8% of 100 mg, 200 mg, and placebo respectively

    • EASI-75 response: 40%, 62%, and 12% of 100 mg, 200 mg, and placebo respectively

  • JADE MONO-2

    • IGA response: 28%, 38%, and 9% of 100 mg, 200 mg, and placebo respectively

    • EASI-75 response: 44%, 61%, and 10% of 100 mg, 200 mg, and placebo respectively

  • JADE COMPARE

    • IGA response: 36%, 47%, and 14% of 100 mg, 200 mg, and placebo respectively

    • EASI-75 response: 58%, 68%, and 27% of 100 mg, 200 mg, and placebo respectively



FDA approved AbbVie's Rinvoq for moderate to severe atopic dermatitis

The US FDA approved AbbVie's Rinvoq (upadacitinib) for treating moderate to severe atopic dermatitis patients who are refractory to systemic therapy. Rinvoq is indicated for adults and children of 12 years and older.

The approval is based on trials in patients with atopic dermatitis. Trials included 2,500 patients; efficacy and safety of 15 mg and 30 mg of Rinvoq were evaluated versus placebo. For patients who do not respond to 15 mg, 30 mg can be administered.

Measure Up 1 (MU1) at week 16

  • EASI 75: 70%, 80%, and 16% of Rinvoq 15 mg, 30 mg, and placebo

  • vIGA-AD 0/1: 48%, 62%, and 8% of Rinvoq 15 mg, 30 mg, and placebo

  • EASI 90: 53%, 66%, and 8% of Rinvoq 15 mg, 30 mg, and placebo

  • EASI 100: 17%, 27%, and 2% of Rinvoq 15 mg, 30 mg, and placebo

  • Worst Pruritus NRS ≥4: 52%, 60%, and 12% of Rinvoq 15 mg, 30 mg, and placebo

Measure Up 2 (MU2) at week 16

  • EASI 75: 60%, 73%, and 13% of Rinvoq 15 mg, 30 mg, and placebo

  • vIGA-AD 0/1: 39%, 52%, and 5% of Rinvoq 15 mg, 30 mg, and placebo

  • EASI 90: 42%, 58%, and 5% of Rinvoq 15 mg, 30 mg, and placebo

  • EASI 100: 14%, 19%, and 1% of Rinvoq 15 mg, 30 mg, and placebo

  • Worst Pruritus NRS ≥4: 42%, 60%, and 9% of Rinvoq 15 mg, 30 mg, and placebo

AD Up at week 16

  • EASI 75: 65%, 77%, and 26% of Rinvoq 15 mg, 30 mg, and placebo

  • vIGA-AD 0/1: 40%, 59%, and 11% of Rinvoq 15 mg, 30 mg, and placebo

  • EASI 90: 43%, 63%, and 13% of Rinvoq 15 mg, 30 mg, and placebo

  • EASI 100: 12%, 23%, and 1% of Rinvoq 15 mg, 30 mg, and placebo

  • Worst Pruritus NRS ≥4: 52%, 64%, and 15% of Rinvoq 15 mg, 30 mg, and placebo


 

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