Good news flowed in at Bristol-Myers Squibb (BMY - Free Report) and partner AstraZeneca (AZN - Free Report) from the UK recently when the National Institute for Health and Clinical Excellence (NICE) issued a Final Appraisal Determination (FAD) for their type II diabetes drug Forxiga (dapagliflozin).
NICE has recommended the use of the product for adults suffering from type II diabetes in combination with metformin and in combination with insulin with or without other oral anti-diabetic drugs in England and Wales.
We note that the FAD will act as the basis for the final NICE guidance. We believe a favorable decision from NICE will increase the access of Forxiga by patients. Forxiga sales in the first quarter of 2013, as recorded by Bristol-Myers, were $3 million.
We remind investors that the European Commission approved Forxiga (once daily) 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.
The EU approval did not come as a surprise as earlier in Apr 2012 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion regarding the approval of Forxiga in the EU.
The US approval path has been bumpy for the drug. In Jan 2012, Bristol-Myers and AstraZeneca received a complete response letter (CRL) 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.
The US regulatory body while issuing the CRL asked for additional data for better assessment of the candidate’s risk-benefit profile. Bristol-Myers intends to resubmit the new drug application to the FDA in mid-2013.
Both AstraZeneca and Bristol-Myers carry a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. and Salix Pharmaceuticals look more attractive with a Zacks Rank #1 (Strong Buy).