FDA raises concerns about ultra-long acting insulins given green light in Europe and Japan

The US drug regulator has announced that it intends to take a close look at the cardiovascular safety of the ultra-long acting insulin degludec next week, because data had indicated that the drug was associated with “an excess risk for cardiovascular events” in comparison with other insulins, it said.

The Food and Drug Administration will assess the safety and efficacy of two products, insulin degludec (marketed as Tresiba) and the combination of insulin degludec and insulin aspart (Ryzodeg) for the treatment of type 1 and type 2 diabetes mellitus at a meeting on 8 November.

A document published by the FDA committee ahead of this meeting said, “This meeting will focus on the cardiovascular safety of two products, insulin degludec/insulin aspart [rDNA origin] and insulin degludec [rDNA origin], as meta-analyses …