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April
12, 2007--An
FDA Advisory Committee voted 20-1 against allowing
Merck’s arthritis painkiller Arcoxia (etoricoxib) to be
sold in the US. The vote is a tough blow for Merck, which
has invested $500 million in the drug and hopes that it
will become a successor to Vioxx (rofecoxib). While the
FDA is not bound to follow the advice of its advisory
committees, it usually does.
In
a press release, Peter Kim, president of Merck Research
Laboratories, said the company was disappointed in the
outcome but is committed to continuing to work with the
FDA on this submission. “We continue to believe that Arcoxia has the
potential to become a valuable treatment option for many
Americans suffering from osteoarthritis," said Kim.
The FDA committee recommended Arcoxia be rejected
because its benefits in reducing pain and minimizing
stomach irritation don't outweigh potential damage to the
heart. Like Vioxx, Arcoxia is a COX-2 inhibitor. Vioxx was
withdrawn from the market in 2004 after being linked to
heart attacks and strokes, wiping out $2.5 billion in
annual revenue for Merck. In 2005, the FDA asked Pfizer to
pull Bextra (valdecoxib), another COX-2 inhibitor, off the
market.
It's
expected that the FDA will make a final decision on
Arcoxia by April 27. The drug is currently available in 63
other countries and brought in $265
million in revenues in 2006. |
