) and partner
Bristol-Myers Squibb Company
) recently announced results from a two-week phase IIa pilot
study (n= 70) on their diabetes drug, Forxiga (dapagliflozin).
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The randomized, double-blind, placebo-controlled, study evaluated
the safety and tolerability of Forxiga as an adjunct to insulin
in type I diabetes patients whose disease was not adequately
controlled. The patients received either Forxiga (1 mg, 2.5 mg, 5
mg or 10 mg) or placebo once daily during the study.
Data from the study revealed that mean daily blood glucose
measured by continuous glucose monitoring declined from the
baseline in the Forxiga arm. Additionally, the proportion of
adverse events excluding hypoglycemia was higher in the placebo
arm (61.5%) as compared to Forxiga groups (38.5%, 46.7%, 50.0%
and 40.0% for 1, 2.5, 5 and 10 mg, respectively).
However, the proportion of hypoglycemia events from the
comparator arms were concerning. The proportion of hypoglycemia
events was 92.3%, 60.0%, 78.6% and 66.7% for the Forxiga 1, 2.5,
5 and 10 mg groups as compared to 61.5% for the placebo arm.
AstraZeneca and Bristol-Myers plan to conduct further studies
evaluating Forxiga in combination with the insulin therapy.
We remind investors that the European Commission approved Forxiga
in the EU, in Nov 2012, for improving glycemic control in adults
suffering from type II diabetes along with lifestyle management
and other glucose-lowering products, such as insulin. Forxiga can
be used as a monotherapy in patients who are intolerant to
metformin. Forxiga sales in the first quarter of 2013, as
recorded by Bristol-Myers, were $3 million.
The US approval path has been bumpy for the drug. In Jan 2012,
Bristol-Myers and AstraZeneca received a complete response letter
from the FDA for Forxiga. The companies were seeking approval of
the drug as an adjunct to diet and exercise for improving
glycemic control in adults suffering from type II diabetes.
Both AstraZeneca and Bristol-Myers carry a Zacks Rank #3 (Hold).
Companies that currently look well-positioned include
). While Biogen is a Zacks Rank #1 (Strong Buy) stock, Novo
Nordisk is a Zacks Rank #2 (Buy) stock.