FDA debates to approve diabetes drug

SILVER SPRING, Md. A much-hyped investigational diabetes drug by Novo Nordisk has left an advisory committee of the Food and Drug Administration split on whether to approve it.

Most members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee found that the drug liraglutide did not pose excessive risk to cardiovascular health, and the board unanimously found the drug approvable, based on data regarding papillary thyroid cancer. But most also found that Novo Nordisk had not ruled out that the finding of C-cell tumors in rodents was not relevant to humans, while being split on the question of whether the available data on C-cell tumors permitted approval.

“We remain convinced that liraglutide has a positive benefit [and] risk profile and represents an important advance for people with Type 2 diabetes,” Novo Nordisk EVP and chief science officer Mads Krogsgaard Thomsen stated. “We will work closely with the FDA as it completes its review of our application to address the concerns expressed by members of the advisory committee.”

The committee reviewed data from 40 clinical studies involving more than 6,800 people with Type 2 diabetes, of whom more than 4,600 were treated with liraglutide.

The company said timing of the launch of the drug in the United States will be determined after completion of the FDA’s review of the application.

The decisions of FDA advisory committees are not binding, but the agency takes them into consideration when deciding whether to approve a drug.