Boston, MA 10/28/2013 (wallstreetpr) – A panel of the U.S. Food and Drug Administration Advisory Committee has recommended for approval of Gilead Sciences, Inc. (NASDAQ:GILD)’s hepatitis C drug sofosbuvir. FDA is not bound to follow the Advisory Committee’s recommendation; however, it has typically done so in the past. This drug is considered more effective than any current treatments for hepatitis C and it also takes less time in treatment process. The recommendation of sofosbuvir was voted unanimously by the Advisory panel. The drug is intended for the patients with genotype 2 and genotype 3 variants of the liver-damaging hepatitis C disease. The drug can be used in combination of existing therapies like ribavirin.
The approval of the drug helps in obviating side effects associated with injectable interferon since it’s an all-oral therapy for genotypes 2 and 3. As such, the approval of the drug is viewed as historic and a game-changer in the healthcare field. The use of this drug will also extend to patients with genotypes 1 and 4 as well as those who have not been through any prior therapy. Genotype 1 is the most prevalent hepatitis C genotype, accounting for nearly 70% of the cases. Presently, treatment for genotype 1 hepatitis C variant include oral drugs called protease inhibitors which include titles such as Victrelis and Incivek.
According to data from the U.S. Center for Disease Control, chronic hepatitis C affects roughly 3 million people in the U.S. With this number of sufferers, analysts project Gilead’s new all-oral drug to generate sales of nearly $1.73 billion in the next financial year. Gilead obtained the rights to sofosbuvir following its 2012 purchase of Pharmasset Inc at a transaction value of $11 billion.
The research-based biopharmaceutical company fell 0.21% in Friday’s trading to complete the run at $69.68. It now has $106.65 billion in market cap. The company discovers, develops and markets medicines.
