New diabetes pill passes FDA heart test
WASHINGTON - A new diabetes pill from Bristol-Myers Squibb Co. and AstraZeneca PLC did not increase the risk of heart attack or stroke in a US review, boosting shares in New York and London as investors bet the drug will be approved.
The medicine, saxagliptin, meets new guidelines for cardiovascular safety, according to a staff report posted yesterday on the Food and Drug Administration's website. Outside advisers to the FDA will consider the findings when they meet tomorrow to discuss whether the companies should be allowed to sell the drug in the United States under the name Onglyza.
Drug makers are striving to introduce new treatments for the 24 million Americans with diabetes, as some older therapies pose heart risks and fail to control blood sugar. Bristol-Myers and AstraZeneca need new products to revive sales and replace drugs facing generic competition, and analysts have been worried that safety concerns at the FDA may preclude saxagliptin's approval.
Saxagliptin is a DPP-4 inhibitor similar to Januvia, a Merck & Co. pill that treats Type 2 diabetes by spurring the pancreas to make more insulin and the liver to produce less glucose, or blood sugar. Januvia had $1.4 billion in 2008 sales.
AstraZeneca agreed in January 2007 to pay Bristol-Myers as much as $1.35 billion for rights to develop and market saxagliptin and another diabetes drug called dapagliflozin.
AstraZeneca's share of annual sales may reach $578 million in 2015 and $893 million by 2018, according to Deutsche Bank AG analyst Brian Bourdot.
An FDA panel will also consider liraglutide, an experimental shot for diabetes made by Novo Nordisk A/S. The agency usually follows the recommendations of its advisers.
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