AstraZeneca (AZN) and partner Bristol-Myers Squibb Company (BMY) recently announced results from a two-week phase IIa pilot study (n= 70) on their diabetes drug, Forxiga (dapagliflozin).
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 Biogen Idec (BIIB) and Novo Nordisk (NVO). While Biogen is a Zacks Rank #1 (Strong Buy) stock, Novo Nordisk is a Zacks Rank #2 (Buy) stock.
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