Both Merck's boceprevir and Vertex's telaprevir earned thumbs up's from the FDA advisory panel this week for the treatment of hepatitis C. Both drugs received an unanimous 18-0 vote to approve from the panel.
In trial data, Vertex's telaprevir improved cure rates of 40% from current standard of care to as high as 80%. Merck similarly made improvements on the standard cure rate 38% up to 65%. Telaprevir could shorten the current course of treatment by half as well.
“Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the committee’s unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C,” said Peter Mueller, Vertex’s chief scientific officer, in a statement. “We look forward to working with the FDA as it prepares to make its decision next month.”
Debra Birkrant, the director of FDA's antiviral-drugs division, according to a report in the Wall Street Journal, said, boceprevir and telaprevir improve cure rates "to more than 30% above what we have today."
The FDA will make the final approval of both drugs official by May 23rd. More than 3 billion people in the US are infected with hepatitis C. Analysts believe both drugs will become blockbusters with annual sales in excess of $2 billion each within a couple of years. Some estimates have both drugs garnering more than $7 billion in annual sales combined at their peak. See Fierce Biotech and Xconomy.
Posted by Bruce Lehr April 30th 2011.