After much expectation, the wait would appear to be over. Pfizer has decided not to pursue commercialization of tenidap 120mg for rheumatoid arthritis, although the osteoarthritis program is still ongoing. Tenidap is thought to have a unique activity profile, including cytokine modulating and lipoxygenase/cyclo-oxygenase inhibition.
The first indication that things were not all well with the project came last May, when a US Food and Drug Administration Advisory Committee recommended that the agency not approve the drug for either rheumatoid arthritis or osteoarthritis on safety grounds, despite the fact that tenidap has been approved by six non-US regulatory authorities (Marketletter May 13). Pfizer has not yet launched the drug in any of these markets.
The FDA has now followed this recommendation by issuing a non-approval letter, and this seems to have put the seal on tenidap for RA.
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