U.S. regulators on Friday approved the use of Johnson & Johnson's Olysio, also known as simeprevir, as a treatment for chronic infection with the liver-destroying hepatitis C virus.
Olysio, a protease inhibitor that blocks a specific protein needed by the virus to replicate, is to be used in combination with interferon, given by injection, and ribavirin, another pill.
Hepatitis C affects about 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer.
The often-undiagnosed virus is transmitted through contaminated blood. Infection rates have dropped since the early 1990s, due in part to the introduction of blood and organ screening. Still, many older adults remain at risk, according to the Centers for Disease Control and Prevention, which has called for baby boomers to be routinely tested for the virus.
Olysio is a member of the same class of drugs as Merck & Co's Victrelis and Vertex Pharmaceuticals' Incivek. The FDA approved both those drugs in 2011.
Olysio was shown in clinical trials to cure patients with a shorter duration of treatment.
Drugmakers have been racing to develop more effective, easier-to-tolerate antivirals to treat hepatitis C. Wall Street analysts have forecast annual sales of billions of dollars for new drugs that would allow doctors to skip use of interferon, which can cause severe flu-like side effects.
The FDA is slated to decide by December 8 on Gilead Sciences' application for sofosbuvir, a member of a different class known as nucleotide analogue inhibitors, or "nukes," designed to block a different enzyme the virus needs to copy itself.
European regulators on Friday recommended approval of the Gilead drug, under the brand name Sovaldi.
Other companies working to develop new hepatitis C drugs include AbbVie and Bristol-Myers Squibb.
(Reporting By Deena Beasley)