Two new hepatitis C therapies fast-tracked in Europe

Two drug combinations from Gilead and AbbVie that could improve treatment of chronic hepatitis C have been granted accelerated review in the EU. Gilead's application is for a three drug combination of NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir and pan-genotypic protease inhibitor voxilaprevir – given over 12 weeks – that could achieve a cure for chronic hepatitis C virus (HCV) patients who have failed other regimens. The new direc

EU health regulator warns some hep C drugs could reactivate hep B

The European Medicines Agency warned on Friday that some of the most successful hepatitis C treatments on the market could reactivate hepatitis B in patients, the second time this year it has raised safety concerns over these treatments. The latest health warning covers some of the top-selling products in the multi-billion dollar hepatitis C market, including Sovaldi, Exviera, Viekirax, Olysio and Daklinza. These drugs cure well over 90 percent of pati

European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

– Epclusa is the First and Only All-Oral, Single Tablet Regimen for all Genotypes (1-6) of Chronic Hepatitis C Virus Infection and is Gilead’s Third Sofosbuvir-Based Treatment – FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 8, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the tre

Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients...

EMA to Review New Hep C Drugs for Possible Hep B Reactivation

The European Medicines Agency (EMA) has launched a review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus infection, the agency said today.They are daclatasvir (Daklinza, Bristol-Myers Squibb), dasabuvir (Exviera, AbbVie), the combination of sofosbuvir and ledipasvir (Harvoni, Gilead Sciences), simeprevir (Olysio, Janssen), sofosbuvir (Sovaldi, Gilead Sciences), and the ombitasvir/paritaprev