It's no easy feat to get a COX-2 inhibitor approved in the U.S. these days. Just ask Merck
COX-2 inhibitors are potent compounds used to treat individuals suffering from osteoarthritis and other pain conditions requiring anti-inflammatory drugs. In its heyday, Merck was selling $2.5 billion worth of Vioxx. But allegations that the drug increased users' risk of cardiovascular disease torpedoed Vioxx's fortunes in 2004, and Merck's still wading through the resulting pile of product liability lawsuits. With sales of approximately $2 billion in 2006, Pfizer's
In April, the FDA rejected Merck's attempt to gain approval for another COX-2 inhibitor, called Arcoxia. The FDA followed the overwhelming sentiment of a panel of federal health advisors, which voted 20 to 1 against the drug's approval. The vote effectively protected Pfizer's command of the U.S. COX-2 inhibitor market. But if Pfizer's celebrating that decision, its jubilation may be short-lived.
On Friday, Swiss pharmaceutical giant Novartis
In retrospect, it's not surprising that the U.S. hasn't yet approved Arcoxia. Just prior to the safety panel's vote, an FDA safety expert testified that the drug may substantially increase patients' risk of stroke and heart attack. I'm sure that this notion weighed heavily on panel members' minds, given the similar concerns that surrounded Vioxx's recall.
It appears that this study by Novartis on Prexige aims to specifically address such concerns, and the latest results are favorable. The FDA may still hesitate to approve another COX-2 inhibitor so after the Vioxx debacle, but Novartis appears to have presented a convincing case for Prexige's relative safety. The potential sales any Celebrex competitor might generate in the U.S., provided it's approved, might make Novartis shares worth a second look for patient Fools.
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