Panel rejects AstraZeneca, Bristol diabetes pill
SILVER SPRING, Maryland
SILVER SPRING, Maryland (Reuters) - U.S. advisers rejected a new type of diabetes pill from AstraZeneca and Bristol-Myers Squibb over concerns about liver and cancer risks.
A Food and Drug Administration advisory panel voted 9-6 on Tuesday against recommending approval of the drug, called dapagliflozin, for adults with Type 2 diabetes.
Panel members said the clinical data did not provide enough certainty about the drug's cancer, liver and kidney risks, as well as its efficacy -- especially for the elderly.
The FDA usually follows the recommendations of its advisory panels and is due to make a final decision on the drug by October 28.
An estimated 200 million people across the world, and close to 26 million in the United States, have diabetes. Most have Type 2 diabetes, the kind linked to poor diet and lack of exercise.
- Alabama man gets $1,000 in police settlement, his lawyers get $459,000
- Doctor who worked in Africa first Ebola case in New York City |
- Exclusive: Charred tanks in Ukraine point to Russian involvement
- Ground offensive against Islamic State months away in Iraq: U.S.
- U.S. stock futures tumble on reports of NY Ebola case