Bristol-Myers Squibb Company
) and partner
) recently received encouraging news with the U.S. Food and Drug
Administration (FDA) acknowledging the receipt of the
re-submitted New Drug Application (NDA) for their diabetes drug
dapagliflozin. A decision from the FDA is expected by Jan 11,
2014. Bristol-Myers/AstraZeneca are looking to get dapagliflozin
approved in the U.S. for treating adults suffering from type II
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We note that this is the second attempt by the companies to get
dapagliflozin approved in the U.S. for the type II diabetes
indication. In Jan 2012, the FDA refused to approve the NDA in
its current form and issued a complete response letter (CRL).
While issuing the CRL, the U.S. regulatory body asked for
additional data. The FDA felt that additional data was required
for assessing the risk-benefit profile of dapagliflozin in a
Following the receipt of the CRL, Bristol-Myers/AstraZeneca
conducted several new studies on dapagliflozin. The companies not
only included data from the new studies in the resubmitted NDA
but also additional long-term data (up to four years' duration)
from earlier studies.
We note that dapagliflozin was approved in the EU in Nov 2012 and
is marketed under the trade name Forxiga for treating type II
diabetes. The drug is also approved in Australia, Brazil, Mexico
and New Zealand. Sales of the drug were only $5 million in the
second quarter of 2013. U.S. approval should significantly
boost the drug's sales potential as the type II diabetes market
is very lucrative. The market includes big players like
Merck and Co.
Bristol-Myers, which has entered a challenging phase following
the genericization of Plavix, carries a Zacks Rank #5 (Strong
Sell). However, all biopharma stocks are not performing as badly
) appears to be very attractive in the biopharma space with a
Zacks Rank #1 (Strong Buy).