A diabetes pill from Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc (AZN) won the backing of U.S. advisers, moving the drug closer to becoming the second in a new class of medicines to treat the disease.
The benefits of the drug outweigh a potential higher risk of bladder cancer and liver toxicity, an advisory panel to the Food and Drug Administration voted 13-1 today at a meeting in Silver Spring, Maryland. The FDA is expected to decide by Jan. 11 whether to approve the drug, known as dapagliflozin.
The FDA rejected the Type 2 diabetes drug in 2012 after a previous panel raised concern about the cancer risk. Research since found the drug may raise the risk of heart attack and stroke soon after starting treatment, though FDA staff said in a report Dec. 10 there is long-term cardiovascular benefit based on the ability to lower blood pressure and aid in weight loss.
“I felt that some of the negative aspects of this drug did not rise to the level of non-approval,” Wyndham Wilson, a panel member and deputy chief at the National Cancer Institute’s Lymphoid Malignancy Branch, said during the meeting. “I think the post-market studies that are planned and under way are addressing the cancer risk, liver risk and cardiac risk.”
Both New York-based Bristol-Myers and London-based AstraZeneca are seeking new drugs to make up for losses from bestsellers that are losing patent protection, including Plavix, Nexium and Seroquel. Dapagliflozin, called Forxiga in Europe where it was approved last year, may generate $125 million in sales for Bristol-Myers next year rising to $1 billion in 2020, according to analysts’ estimates compiled by Bloomberg.
The FDA approved Johnson & Johnson (JNJ)’s Invokana in March for Type 2 diabetes that was the first in a class of therapies called SGLT2s, which expel sugar in the urine after the kidneys filter it from the blood. Invokana showed the same potential heart risk early in treatment as dapagliflozin.
Dapagliflozin data showed the drug carries an acceptable cardiovascular risk, the panel voted 10-4. The FDA isn’t obligated to follow the panel’s recommendations.
J&J was required as part of the approval to study the effects of Invokana on the heart while it’s on the market. Bristol-Myers and AstraZeneca have proposed post-market surveillance in an ongoing cardiovascular study for their drug.
Out of 6,045 patients in clinical trials for dapagliflozin, 10 were diagnosed with bladder cancer compared to one out of 3,512 patients who took a placebo or older treatments.
Diabetes is the seventh-leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. The disease, defined by high levels of sugar in the blood, affected almost 26 million people in the U.S. in 2010, or about 8.3 percent of the population, the CDC said.
Boehringer Ingelheim, based in Ingelheim, Germany, and Eli Lilly & Co. (LLY), based in Indianapolis, submitted an application for FDA approval of their SGLT2 inhibitor empagliflozin, the companies said in a March 25 statement. Astellas Pharma Inc. (4503) is also working on an SGLT2 inhibitor known as ipragliflozin.
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