The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Merck & Co.’s 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 European Union (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 US Food and Drug Administration and Health Canada approved Zepatier 50-mg/100-mg tablets in January 2016. In the United States, Zepatier is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin.

Zepatier is positioned as a potential blockbuster. The drug is an once-daily, fixed-dose combination tablet containing the NS5A inhibitor, elbasvir, and the NS3/4A protease inhibito,r grazoprevir. The FDA previously granted two breakthrough therapy designations to Zepatier, for the treatment of chronic HCV GT1 infection in patients with end-stage renal disease on hemodialysis and for the treatment of patients with chronic HCV GT4 infection.

A recent Thomson Reuters analysis projects 2020 sales for Zepatier of $1.537 billion. Zepatier is one of several interferon-free therapies competing in the HCV market. Other key drugs include Gilead's Harvoni (sofosbuvir and ledipasvir) and AbbVie's Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets). Current forecasts project sales of $9.335 bilion for Harvoni and $1.749 billion for Viekira Pak in 2020, according to Thomson Reuters. Sales of Zepatier are projected at $636 million in 2016 and rising to $1.5 billion by 2020.

Source: Merck & Co.