EMA's CHMP advisory unit decisions include good news for Lilly, Bristol-Myers, Boehringer and Roche

Following meetings last week of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), a number of positive opinions were adopted. Among these, the Committee adopted positive opinions recommending the granting of marketing authorizations for the following new medicines:

* Bydureon (exenatide), from Eli Lilly and partner Amylin, intended for the treatment of type-2 diabetes in adults. "The CHMP's positive opinion is a pivotal step toward marketing authorization for Bydureon in Europe. If approved, Bydureon will offer patients the benefits of a GLP-1 receptor agonist in a once-weekly injection," said Enrique Conterno, president, Lilly Diabetes.

* Nulojix (belatacept), from Bristol-Myers Squibb, intended in combination with corticosteroids and a mycophenolic acid for prophylaxis of graft rejection in adults receiving a renal transplant.