The Food and Drug Administration has demanded additional tests of potential heart risks in a new long-acting insulin, potentially delaying its approval in the U.S. until 2015 or 2016.
Novo Nordisk, the Danish drug maker and world's biggest insulin maker, had been banking on the drug Tresiba to keep it in the lead in diabetes care. Tresiba and Ryzodeg have been widely predicted to become multibillion-dollar sellers worldwide, but concerns about their cardiovascular safety still remain, even after being approved in Europe and Japan.
The FDA's decision to issue Novo a complete response letter signifies the company's application cannot be approved in its existing form.
"We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review," said Lards Rebien Sorensen, Novo's chief executive, in a statement. Read the full details here:
F.D.A. Demands More Tests of Novo Nordisk's New Insulin to Gauge Heart Risks
The FDA is finally looking into the possible bad side effects of medication before putting them on the market, despite some good effects. Too often drug companies are successful in rushing their defective drugs and products to the market before they are adequately tested thereby resulting in wrongful death and product liability claims.
If you or someone you love has been injured by a defective product, drug, or malpractice, call the professionals at Crandall & Pera Law for a free case evaluation.