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Home Industry News Merck Sharp and Dohme’s Zepatier recommended for EU approval

Merck Sharp and Dohme’s Zepatier recommended for EU approval

31st May 2016

Merck Sharp and Dohme has announced that its new drug hepatitis C drug Zepatier has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion on the approval of the investigational once-daily fixed-dose combination tablet for the treatment of chronic hepatitis C virus in adult patients.

This comes after the drug was previously given the green light by regulators in the US and Canada earlier this year.

With a final decision from the European Commission expected in mid-2016, the company is now seeking to achieve manufacturing readiness to supply the EU market. Product launches are estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.

Dr Roy Baynes, senior vice-president and head of clinical development at Merck Research Laboratories, said: "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."

The company reported clinical data demonstrating the safety and efficacy of the drug at the International Liver Congress in Barcelona last month.ADNFCR-8000103-ID-801819403-ADNFCR

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