The cancer and liver toxicity risks of Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc (AZN)’s diabetes medicine may outweigh any benefit the drug has on the heart, U.S. regulators said.
The pill, potentially the second to reach the market in a new class of diabetes drugs, has cardiovascular benefit including lower blood pressure and weight loss. Food and Drug Administration staff members were wary that the heart benefits were enough to balance an increased risk of bladder cancer and indications of liver damage, according to a report posted today ahead of a Dec. 12 meeting of advisers to the agency.
The FDA rejected dapagliflozin in January 2012 after a previous advisory panel raised concern about the potential association with cancer. Today’s report cited trials showing increased liver enzymes that indicate damage to the organ of those who took the diabetes pill and an increased potential for heart attack and stroke soon after starting treatment, though FDA staff said there is a long-term cardiovascular benefit.
“As a result of these updated analyses the agency could not conclude with any level of confidence that the purported CV-benefit associated with dapagliflozin use outweighed the observed imbalance in specific malignancies or potential liver toxicity risks,” Jean-Marc Guettier, director of the FDA’s endocrinology product division, wrote in today’s report.
The FDA is scheduled to decide whether to approve the diabetes treatment by Jan. 11. The agency approved Johnson & Johnson (JNJ)’s Invokana in March for Type 2 diabetes that was the first in a class of therapies like dapagliflozin called SGLT2s, which expel sugar in the urine after the kidneys filter it from the blood. New Brunswick, New Jersey-based J&J must study the effects of the pill on the heart while its on the market.
Graham
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