(PFE) Pfizer Drug Review Period Extended by FDA

The US Food and Drug Administration (FDA) recently extended its review period for Pfizer’s (PFE) rheumatoid arthritis (RA) candidate, tofacitinib. The FDA will deliver a decision regarding the approvability of tofacitinib by November 21, 2012. Pfizer is looking to get tofacitinib approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

The 3-month extension in the review period does not come as a surprise. Earlier this year, the FDA’s Arthritis Advisory Committee had voted 8-2 in favor of tofacitinib. However, the FDA later asked the company to submit additional analysis of the existing data as part of the new drug application (NDA). Importantly, the agency did not ask the company to conduct additional studies.

With Pfizer submitting the additional analysis earlier this month, the extension in the FDA review period was expected. In fact, Pfizer had mentioned on its second quarter call that it expects the FDA to require more time to review the additional analysis.

FDA approval would make tofacitinib the first new oral disease-modifying antirheumatic drug (DMARD) to be approved for rheumatoid arthritis in more than 10 years. Moreover, tofacitinib would be the first Janus kinase (JAK) inhibitor to be approved for rheumatoid arthritis. Pfizer is also seeking approval for tofacitinib in several other regions including the EU and Japan.

Tofacitinib is one of the most promising candidates in Pfizer’s pipeline. In late July 2012, Pfizer had reported positive top-line results on tofacitinib from a phase III study (ORAL Start). The study, conducted in methotrexate (MTX)-naïve patients with moderate-to-severe active RA, met its primary endpoints at both doses of tofacitnib (5 and 10 mg) that were evaluated.

Last year, the company had presented encouraging data on tofacitinib from another phase III study. Tofacitinib met its primary endpoint in the ORAL Sync phase III study (A3921046), which was conducted with patients suffering from moderate-to-severe rheumatoid arthritis. Results showed that compared to placebo, tofacitinib achieved a statistically significant reduction in signs and symptoms of rheumatoid arthritis.

Being an oral treatment, tofacitinib could have an edge over existing therapies which need to be injected or administered through infusion. The rheumatoid arthritis market currently has treatments like Abbott’s (ABT) Humira and Johnson & Johnson’s (JNJ) Remicade and Simponi among others.

We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term ‘Hold’ rating).

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