The US Food and Drug Administration (FDA) recently extended its
review period for
) 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
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
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
) Humira and
Johnson & Johnson
) 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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