Fierce Biotech reported yesterday that Merck announced that both the FDA and EMA have accepted its application for boceprevir for expedited review. Meanwhile, Vertex is still waiting on confirmation from the FDA on its application for telaprevir. Both drugs are for the treatment of hepatitis C infections.
Regulatory watchers expect both drugs to be approved sometime during 2011 and then the real race will be on for sales in the hepaitis C treatment market. Both drugs are expected to have a big impact on the status of current therapies for the teatment of chronic hepatitis C infections.
Posted by Bruce Lehr Jan 7th 2011.