SEPTEMBER 2020 CHMP Opinions
MenQuadfi and Supemtek
In Europe, CHMP gave a positive recommendation for Sanofi’s vaccine candidates, MenQuadfi and Supemtek.
MenQuadfi is indicated for the active immunization of individuals from the age of 12 months and older against meningococcal ACWY disease. The approval is based on the clinical trials, which demonstrate an immune response against serotype A, C, W, and Y.
Sanofi submitted seven double-blinded, randomized, multicenter, Phase 2, and Phase 3 clinical trials, demonstrating the immune response of the vaccine in toddlers of 12 months and older.
The vaccine is expected to available in the European market from the beginning of next year.
Sanofi also received a positive recommendation for another vaccine, Supemtek (quadrivalent recombinant influenza vaccine), development for the prophylaxis of influenza in adults 18 years and older.
The approval is based on Phase 3 randomized trials involving more than 10,000 patients. The risk of influenza was reduced by more than 30% in adults age 50 years and older.
Supemtek relies on recombinant manufacturing technology. The drug is already approved in the U.S., and Sanofi has supplied more than 10 million doses of vaccine.
OLUMIANT FOR ATOPIC DERMATITIS
Eli Lilly received the CHMP positive opinion for baricitinib for treating adults with moderate to severe atopic dermatitis.
Olumiant (baricitinib) is the first JAK inhibitor to receive the CHMP positive opinion for atopic dermatitis.
The CHMP positive opinion was received based on Phase 3 BREEZE-AD clinical trials. BREEZE-AD1 and BREEZE-AD2 were designed to investigate the efficacy and safety of baricitinib in patients with moderate to severe atopic dermatitis as monotherapy, BREEZE-AD4 was intended to demonstrate the efficacy of baricitinib in combination with corticosteroids in patients who have failed or intolerant or contraindicated to corticosteroids.
The product was prior approved in more than 70 countries for rheumatoid arthritis.
AstraZeneca and MSD’s Lynparza have received the CHMP positive opinion for treating patients with metastatic castration-resistant prostate cancer (mCRPC).
AstraZeneca and MSD have presented the PROfound Phase III trial to support the CHMP positive opinion. The progression-free survival was considered as the primary endpoint; the progression-free survival was 7.4 months in the Olaparib group compared to 3.6 months in the control group. The median overall survival was 18.5 months in the Olaparib group versus 15.1 months in the placebo group.
Lynparza has received the approval for metastatic prostate cancer in May 2020.
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