Merck receives positive CHMP opinion for Zepatier (elbasvir and grazoprevir) in the EU
Product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.
Merck (MSD) has 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. The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the EU, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Merck anticipates that the European Commission decision will be made in mid-2016. The company continues to work to achieve manufacturing readiness to supply the EU market, with product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.
The FDA and Health Canada approved Zepatier 50 mg/100 mg tablets in January 2016. In the US, Zepatier is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin (RBV). “We are pleased with the CHMP’s positive opinion recommending the marketing authorization of Zepatier in the EU, which marks an important step forward in the European regulatory process,” said Dr Roy Baynes, senior vice president and head of clinical development, Merck Research Laboratories. “Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of Zepatier across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.”
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance