) recently received a boost with the U.S. Food and Drug
Administration's (FDA) Arthritis Advisory Committee voting 8-2 in
favor of the company's rheumatoid arthritis candidate,
Pfizer is looking to get tofacitinib approved for the treatment
of adult patients with moderately to severely active rheumatoid
While the FDA is not required to follow the advice of its
advisory panels, it usually does so. A response on the approval
status of tofacitinib should be out by August 2012.
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 E.U. and
Tofacitinib is one of the most promising candidates in Pfizer's
pipeline. Last year, the company had presented encouraging data on
tofacitinib from a 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
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
players like products like
) Humira and
Johnson & Johnson's
) 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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