- The European Medicines Agency (EMA) last week recommended approval for two combination hepatitis C treatments from Gilead and Merck, setting up an expansion of treatment options for European patients with the liver disease.
- Merck's Zepatier and Gilead's Epclusa will now go to the European Commission for a final decision on marketing authorization. While Zepatier is already on the market in the U.S., Epclusa is still under FDA review for approval there.
- Epclusa is a combination of sofosbuvir, already approved by itself as Sovaldi, and velpatasvir, an investigational NS5A inhibitor.
Gilead's Epclusa was recommended as a pan-genotypic treatment, a notable difference from Merck's Zepatier, which is only aimed to genotypes 1 and 4.
Merck is attempting to challenge Gilead's dominant position in the global hepatitis C market through its launch of Zepatier. Both Zepatier and Gilead's market-leading Harvoni offer similar levels of efficacy and a relatively clean safety profile. But Harvoni has a more flexible treatment regimen and an established market position.
First-quarter sales for Zepatier in the U.S. totaled only $50 million, although Merck noted positive signs from its launch.
The EMA's recommendation sets up a final decision on approval later this year, likely this summer. Merck estimated product launches would begin in the fourth quarter or the first quarter of 2017.
Pricing and reimbursement decisions for Zepatier (and Epclusa) will be undertaken by each EU country following a final approval by the European Commission. In the U.S., Zepatier is priced significantly below Gilead's Harvoni.
For Gilead, marketing authorization for Epclusa would add deepen its portfolio of hepatitis C treatments and give it a drug for use across genotypes. Although genotype 1 is by far the most prevalent, a lower share of hepatitis C patients in Europe have genotype 1 than in the U.S. (63% and 79% respectively), according to Gilead.
Gilead has submitted an application for Epclusa's approval to the FDA, with a target action date of June 28.