The Week in Review: July 28 – August 4, 2017

Friday, August 4, 2017 Treatment: This last week saw the approval in the U.S. of AbbVie’s Mavyret, a pangenotypic also indicated as recuperation therapy for those with GT1 who have failed treatment with DAAs. U.S.: FDA approves Mavyret for Hepatitis C As well, the FDA has approved updated labeling for Epclusa to include use in patients co-infected with HIV. U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatmen...

WHO approves generic drug to treat hepatitis C

The World Health Organization has approved the first generic version of sofosbuvir, a critical drug in the treatment of hepatitis C. This development could expand access to treatment by increasing the number of quality-assured generic medicines in the market. Sofosbuvir, a 400mg tablet, is manufactured by Mylan Laboratories Ltd India. “This is a breakthrough medicine with a 95-per cent cure,” Suzanne Hill, director of essential m...

WHO prequalifies first generic active ingredient for hepatitis C medicines

On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir. Sofosbuvir is an essential ingredient for new, highly effective medicines to treat hepatitis C called direct active antivirals (DAAs). The prequalified product’s manufacturer is Mylan Laboratories Ltd - INDIA. The emergence of DAAs in 2014 gave new hope to the 80-110 million people suffering from chronic hepatitis C, a disea

Mylan enters MPP agreement over affordable hepatitis C generics

Mylan has entered into a sub-licensing agreement with the Medicines Patent Pool (MPP), a UN-backed public health organisation, to expand access to chronic hepatitis C medicines in developing countries. Under the agreement, announced yesterday, November 28, Mylan will produce and market a generic version of Bristol-Myers Squibb’s Daklinza (daclatasvir). The generic drug will be distributed in 112 low and middle income countries. Source: