FDA Panel Rejects Pfizer's Tenidap Application

Pfizer's long-awaited drug for rheumatoid and osteoarthritis, Enable (tenidap) failed to secure a recommendation for approval by the US Food and Drug Administration's advisory committee, to the great disappointment of the company and arthritis sufferers alike.

The panel declined to recommend approval on the grounds that the drug's safety was still in question. Citing concerns about bone mineralization loss in some patients who took the drug during trials, as well as a problem with protein in patients' urine, the panel voted that it could not support approving the compound for either RA or osteoarthritis.

Tenidap has been widely tipped as an important new drug, both for Pfizer and arthritis suffers. Indeed, just prior to the announcement, Lehman Brothers' Jerome Brimeyer reiterated his outperform rating for the company, saying "we expect a recommendation for FDA approval for both rheumatoid arthritis and osteoarthritis with final FDA approval by year-end." Mr Brimeyer forecast sales of $700 million within five years.