We continue to find the results of research that help individuals with diabetes have more medication and other tools to control diabetes and the symptoms that go with it. One new discovery is 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 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.
The FDA review of saxagliptin focused primarily on six core studies submitted by Bristol-Myers and AstraZeneca that followed patients for at least one year after the initial three-to-six month study period. It found an overall low rate of major cardiovascular events, according to Monday’s documents. In higher-risk patients, the rates appeared to be similar between patients taking saxagliptin and those getting a placebo or, in one study, the popular diabetes drug metformin, at about 2%.
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.
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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