) supplemental new drug application (sNDA) for Xeljanz was
recently accepted by the US Food and Drug Administration (FDA)
for review. The company is looking to expand the label to include
inhibition of progression of structural damage. The FDA's
decision regarding the label expansion should be out by Feb
We note that Xeljanz was approved in the US in early Nov 2012
for the treatment of moderately to severely active rheumatoid
arthritis (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. The product
represents a new treatment option for patients who respond
inadequately to or are unable to tolerate MTX.
Xeljanz sales were $11 million in the first quarter of 2013.
Pfizer said that initial Xeljanz trends are encouraging with
rheumatologist prescriptions trending higher. The company also
reported an increase in repeat prescriptions. Pfizer intends to
commence a DTC campaign this summer.
Pfizer is currently evaluating Xeljanz for additional
indications. Apart from the indication currently under review,
Pfizer is evaluating Xeljanz in phase III studies for psoriasis
with results due shortly. Positive results would allow the
company to file for FDA approval early next year. Pfizer is also
looking to move Xeljanz into a phase III study for psoriatic
arthritis later this year.
While we are pleased with Xeljanz' progress in the US, we note
that it is yet to gain approval in the EU. In Apr 2013, Pfizer
announced that the European Medicines Agency's (EMA) Committee
for Medicinal Products for Human Use (CHMP) issued a negative
opinion for Xeljanz for the treatment of adults with
moderate-to-severe active RA.
According to the CHMP, Xeljanz's risk-benefit profile is not
favorable currently and therefore should not be approved. Pfizer
said that it will appeal this opinion and seek a re-examination
of the same.
Pfizer currently carries a Zacks Rank #4 (Sell). The company
recently lowered its earnings and revenue outlook for 2013
following the divestment of its stake in its former animal health
Among large-cap pharma companies,
) currently looks well-positioned with a Zacks Rank #2 (Buy).
), which is a Zacks Rank #1 (Strong Buy) stock, also looks
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