(BMY) Bristol-Myers Squibb Gets Good News From the FDA

March 3rd, 2010

Recently, Bristol-Myers Squibb Co. (BMY) announced that the advisory committee of the U.S. Food and Drug Administration (FDA) recommended approval for belatacept, the company’s candidate for treating patients undergoing kidney transplants.

The panel voted in favor of approving the drug despite mixed results compared to older therapies from Abbott Laboratories (ABT) and Novartis (NVS). The favorable recommendation was made primarily to provide physicians and patients with more treatment choices.

Thirteen of the 18 members of the advisory panel voted in favor of approving belatacept to prevent the rejection of a new kidney in transplant patients. Bristol-Myers is seeking FDA approval for the injectable drug to prevent organ rejection and maintain kidney function in patients suffering from end-stage renal disease.

The Biologics License Application (BLA) for belatacept was accepted by the U.S. regulatory authority for review in Sept 2009. The FDA is expected to decide on the fate of the candidate by May 1, 2010 (the target date). Although the regulatory authority is not bound to accept the recommendation of the advisory panel it does pay heed when reviewing new drug applications.

The advisory committee’s recommendation was based on data from the belatacept clinical development program, which included more than 1,000 patients who received belatacept. The data comprised of safety and efficacy results from three similarly designed trials: a mid-stage study and two late-stage studies.

However, nearly all the members of the panel agreed that follow-up studies should be conducted by Bristol-Myers to evaluate the long-term safety of the candidate. Majority of the patients in Bristol’s study were followed for just 2 years.

Currently, we are Neutral on Bristol-Myers Squibb. The recommendation implies that the stock is expected to perform in line with the overall U.S. equity market over the next six to twelve months. Therefore, we advise investors to retain the stock over this time period.

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More on this topic (What's this?)
Bristol-Myers Squibb, Two other companies raise dividends (Dividend Growth Investor, 12/28/09)
Bristol-Myers Gets a Shot in the Arm (Wall Street Sector Selector, 6/7/10)
Bristol-Myers Squibb, Two other companies raise dividends (The Wikinvest Daily Angle, 12/28/09)
Industrial Review On Bristol Myers Squibb Co. (Penny Stock DD, 1/10/12)
Read more on Bristol-Myers Squibb Company at Wikinvest

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