) recently released encouraging top-line results from a
randomized, placebo-controlled trial, CAPiTA (Community-Acquired
Pneumonia Immunization Trial in Adults) on pneumonia vaccine
Prevenar 13 was approved by the U.S. Food and Drug
Administration (FDA) under an accelerated approval process.
As part of its regulatory commitments under the FDA's
accelerated approval program, Pfizer conducted the CAPiTA study
to verify the clinical benefit of Prevenar 13 for adults.
The trial evaluated the efficacy of Prevenar 13 in preventing
the first episode of community-acquired pneumonia (CAP) caused by
the serotypes contained in the vaccine. The trial met its primary
The CAPiTA study met both the secondary endpoints as well -
efficacy against a first episode of non-bacteremic/non-invasive
vaccine-type CAP and a first episode of vaccine-type invasive
pneumococcal disease (IPD). Pfizer expects to provide detailed
results in Mar 2014.
We remind investors that in Feb 2012, the U.S. Centers for
Disease Control and Prevention's Advisory Committee on
Immunization Practices (ACIP) indicated that it will defer voting
on a recommendation for the routine use of Prevenar 13 in adults
50 years of age and older until the results of CAPiTA are out.
The ACIP also needs data on the impact of pediatricuse of
Prevenar 13 on the disease burden and serotype distribution among
adults for a favorable recommendation.
The encouraging results from the CAPiTA study will be
instrumental in gaining a positive recommendation from the
Meanwhile, the FDA approved Pfizer's supplemental New Drug
Application (sNDA) for rheumatoid arthritis (RA) drug,
The approval updates the current label of Xeljanz 5 mg tablets
to include encouraging radiographic data from two phase III
studies, ORAL Scan and ORAL Start. The results from both the
studies showed a reduction of radiographic progression.
We note that Xeljanz was approved in the U.S. in early Nov
2012 for the treatment of moderately to severely active RA in
adult patients who have not responded adequately to or cannot
tolerate methotrexate (MTX). Xeljanz is the first oral treatment
to gain approval in a new class of medicines known as Janus
kinase (JAK) inhibitors.
We are encouraged by the recent bout of positive news from
Pfizer. Pfizer currently carries a Zacks Rank #3
(Hold). Some better-ranked stocks in the sector
Alexion Pharmaceuticals, Inc.
). While Alexion and Biogen hold a Zacks Rank #1 (Strong
Buy), Actelion carries a Zacks Rank #2 (Buy).
ACTELION LTD (ALIOF): Get Free Report
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