Tags : Marketing Authorization

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval

Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and […]Read More

AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives EC’s Marketing Authorization as Eight-Week Regimen

Shots: The approval is based on P-IIIb EXPEDITION-8 study assessing Maviret in 343 treatment naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6) for 8wks. The P-IIIb EXPEDITION-8 study results: GT1- 6 patients achieving SVR12 (97.7%); GT3 patients achieving SVR12 (95.2%); one case of virologic failure and no case of discontinuation was […]Read More

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives European Commission Marketing Authorization for

Shots: The marketing authorization is based on GEMINI 1 & 2 studies result assessing Dovato vs dolutegravir + tenofovir disoproxil fumarate/emtricitabine in 1400+ patients with HIV-1 infection for 48wks. The GEMINI 1 & 2 studies result demonstrated that two drug regimen showed non-inferior efficacy based on plasma HIV-1 RNA <50 copies/ml compared three-drug regimen in […]Read More