- Gilead won European approval for its new pan-genotypic hepatitis C drug Epclusa, roughly two weeks after U.S. regulators gave the drug a green light.
- The European Commission authorization helps bolster Gilead's hepatitis C franchise in Europe, adding a third option to its market-leading drugs Harvoni and Sovaldi.
- Gilead relied on the same phase 3 trials from the "Astral" clinical development program, which were also used to support approval in the U.S. In clinical trials, Epclusa eliminated detectable virus in the blood for between 95% and 99% of patients.
Epclusa is the first single-pill drug approved in Europe to treat hepatitis C genotypes 2 and 3, adding an important option for European patients with those subsets of the liver disease.
Although Europe has a smaller population of hepatitis C patients than the U.S., fewer of those patients have the easier-to-treat genotype 1. Given the broad range of treatment options for genotype 1, Epclusa could be better positioned to secure market share than typical of a late entrant to a crowded market given its pan-genotypic approval.
Gilead's chief executive John Milligan noted 15 million patients are chronically infected with hepatitis C in Europe, although the company has previously estimated there are around 2.6 million patients in the "big 5" European countries.
Another factor in favor of Epclusa is that it can be used to treat hepatitis C in patients both with or without cirrhosis. For patients with moderate-to-severe cirrhosis, however, Epclusa is approved only for use in combination with ribavirin.