FDA panel back Bristol-Myers transplant drug
Federal health advisers say an organ transplant drug from Bristol-Myers Squibb Co. should be approved for patients receiving a new kidney.
The Food and Drug Administration panel has voted 13-5 in favor of the company's drug belatacept to prevent organ rejection in patients implanted with a new kidney.
FDA is not required to follow the group's advice.
Bristol has presented its drug as a new alternative to decades-old transplant drugs that cause headaches, nausea and occasional liver toxicity.
Belatacept patients in a study showed improved kidney function and lower blood pressure, key indicators of survival.
However, FDA drug reviewers noted higher rates of severe kidney rejection in patients compared with older drugs.