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FDA committee supports approval of Pfizer's tofacitinib for RA

Wednesday, May 09 2012 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration's Arthritis Drugs Advisory Committee voted 8-2 to recommend approval of Pfizer Inc.'s tofacitinib for the treatment of patients with moderately to severely active rheumatoid arthritis (RA).

However, the panel recommended follow-up studies to evaluate the drug's long-term side effects, according to The Associated Press.

Earlier this week, staff members from the FDA said in documents posted on its website that the drug was associated with "serious safety concerns."

In the documents, the staff reviewers said all five Phase III trials of tofacitinib provide consistent evidence of improvement in the signs and symptoms of RA. However, the reviewers said it was not possible to make definitive conclusions about the treatment effect of tofacitinib on structural damage progress, which they noted is particularly important in determining the drug's overall benefit-risk profile.

In terms of safety, the FDA reviewers expressed concern about a possible risk of malignancy--overall, and a risk of lymphoma in particular--as well as serious infections, abnormal hematologic parameters, lipid parameter changes and the drug's cardiovascular safety profile. 

Pfizer, in separate briefing documents, stated that tofacitinib "has demonstrated, through an extensive clinical program, a manageable safety profile and robust efficacy when dosed orally as 5 mg and 10 mg [twice daily], either as monotherapy or on background disease-modifying antirheumatic drugs [DMARDs]."

The company added that the benefit-risk profile of the drug is "consistent with that of biologic therapies currently used in patients that have had an inadequate response to prior DMARD therapy."

The FDA is scheduled to decide whether to approve tofacitinib in August.

If approved, tofacitinib would be the first new oral DMARD approved for RA in more than 10 years and the first Janus kinase inhibitor approved for treating RA, Pfizer noted.

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