APRIL 2022 - CHMP OPINIONS
NEW INDICATION APPROVALS
CHMP gave a positive opinion for Amryt Pharmaceuticals' Filsuvez (birch bark extract) for treating epidermolysis bullosa (EB). EB is a rare skin disorder impacting pediatric and adult patients. The approval is based on the Phase 3 EASE trial.
Roche's Lunsumio (mosunetuzumab) received a positive CHMP opinion for treating follicular lymphoma patients who were previously treated with two other therapies. The approval was based on the GO29781 study, in which Lunsumio showed high complete response rates. After a median follow-up of 18.3 months, the CR rate was 60%, and progression-free survival was 17.9 months. The median duration of response in patients who responded was 22.8 months.
CHMP gave a positive opinion for Novartis' Tabrecta (capmatinib) for treating patients with METex14 advanced non-small cell lung cancer. The approval was based on the Phase II GEOMETRY mono-1 study. In all the patients, the median duration of response was 9.7 months; the median overall survival was 13.6 months in the previously treated population.
Bydureon (exenatide) was extended to the indication for pediatric patients (adolescents and children aged ten years and above).
Elonva (corifollitropin alfa) received an indication extension for treating adolescent males (14 years and older) with hypogonadotropic hypogonadism.
Keytruda got a positive opinion for triple-negative breast cancer. Keytruda was indicated in combination with chemotherapy as neoadjuvant treatment, followed by continuation after surgery as monotherapy.
NovoSeven (eptacog alfa (activated)) received a positive CHMP opinion for severe postpartum hemorrhage.
Tecentriq got a positive opinion for early-stage non-small cell lung cancer (NSCLC).
Yescarta received a positive opinion for follicular lymphoma after three or more lines of systemic therapy.
Biogen has withdrawn the market authorization application of Aduhelm (aducanumab), a medicine indicated for treating Alzheimer's disease.
ARS Pharmaceuticals withdrew the application of Neffy, a treatment indicated for treating allergic reactions, including anaphylaxis.
Orphazyme withdrew the market authorization application of its Niemann-Pick disease type C therapy, Miplyffa (arimoclomol).
MARCH 2022 - CHMP POSITIVE OPINIONS
Mar 25, 2022
Janssen's Carvykti received CHMP positive opinion for treating relapsed and refractory multiple myeloma patients.
CHMP gave position for treating Carvykti (ciltacabtagene autoleucel) for treating relapsed and refractory multiple myeloma.
The approval was based on a single-arm, open-label study in 113 adult patients with relapsed and refractory multiple myeloma. The patients were previously treated with three other therapeutic options. 84% of patients had a durable response, and 69% showed a complete response.
AstraZeneca's COVID-19 medicine Evusheld received CHMP positive opinion
AstraZeneca's Evusheld received CHMP positive COVID-19 in adults and adolescents from 12 years. The approval was based on the trial, which enrolled more than 5,000 people. The risk of COVID-19 infection was reduced by 77% after two injections of 150 mg tixagevimab and 150 mg cilgavimab.
CHMP Opinions - January 2022
BMS' Breyanzi (isocabtagene maraleucel) received a positive CHMP for treating relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma. Breyanzi is gene therapy indicated in patients previously treated with two other treatments. The drug has previously received PRIME designation from EMA. The positive opinion is based on TRANSCEND NHL 001 and TRANSCEND WORLD study.
Pfizer's Paxlovid received CHMP positive opinion for treating COVID-19. The approval is based on the decreased hospitalizations and deaths in patients infected with COVID19 infection. After a month of treating with Paxlovid, 0.8% of patients on Paxlovid were hospitalized compared to 6.3% of patients on placebo. No deaths were reported in the Paxlovid group compared to 12 deaths in patients on placebo. Most of the patients enrolled in this study have Delta variant; however, laboratory studies showed that the drug is also effective against the Omicron variant.
Further, there are eight indication extensions.
Ayvakyt: Blueprint Medicines Ayvakyt (avapritinib) received an indication extension for aggressive systemic mastocytosis (ASM). Previously, it is approved for unresectable or metastatic gastrointestinal stromal tumors.
Briviact: Briviact (brivaracetam) received positive opinion for two years and older patients with epilepsy
Dupixent: Dupixent (dupilumab) received positive opinion for indication extension. Now, Dupixent can be used for pediatric patients for treating asthma who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) in addition to other products.
Jardiance: Jardiance (empagliflozin) was previously approved for heart failure - it is now received a positive opinion for all patients with symptomatic chronic heart failure.
Lacosamide UCB: Lacosamide UCB received a positive opinion for approval for two years and older patients with epilepsy. Previously it was approved for four years and older patients.
Senshio: Senshio received a positive opinion for moderate to severe symptomatic vulvar and vaginal atrophy (VVA).
Tecfidera: Biogen's Tecfidera (dimethyl fumarate) received a positive CHMP for patients aged 13 years and older. Previously, it was approved for adults only.
Vimpat: UCB's Vimpat (lacosamide) received a positive CHMP for two years and older pediatrics. Previously, it was approved for patients of 4 years and older.
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