Gilead to seek okay for combo hepatitis C pill in Q1
Dec 18 (Reuters) - Gilead Sciences Inc, based on favorable new clinical trial data, said it will seek U.S. approval in the first quarter of 2014 for a once-daily tablet containing two new treatments for hepatitis C.
The company previously had said it would seek marketing approval in the first half of next year for the combination tablet, which would pair Gilead's recently approved Sovaldi (sofosbuvir) and its experimental drug ledipasvir.
In clinical trials, the combination of drugs produced high cure rates in patients with the most common, but hardest to treat, genotype 1 strain of the liver virus. And it did it without patients having to take the standard injectable treatment interferon, which causes flu-like symptoms.