2022 FDA Drug Approvals

Updated: May 11

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).

Also read: USA and Canada Healthcare and Pharma News


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.



Also read: China healthcare system


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.


Also read: China healthcare system


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.

Also read: The US Healthcare System


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.


Also read: China healthcare system


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.


Also read: The US Healthcare System


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.


Also read: The US Healthcare System

In, TENAYA and LUCERNE Studies, Roche compared Vabysmo versus aflibercept. The average change in the best-corrected visual acuity (BCVA) score is the primary endpoint. 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.

Also read: Japan Healthcare System


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.

Also read: China healthcare system


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.

Also: Australia drug approvals

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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