Xultophy, Accofil and Busulfan recommended by EMA/CHMP

At its July 2014 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for the recommendation of a number of new drugs, including the following:

The CHMP has recommended granting marketing authorisations Xultophy (insulin degludec/liraglutide), from Danish diabetes care giant Novo Nordisk (NOV: N). The CHMP positive opinion recommends that Xultophy will be indicated for the treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycemic control. A pharmacovigilance plan for Xultophy will be implemented as part of the marketing authorization, said the EMA.

Novo Nordisk expects to receive final marketing authorization from the European Commission within around three months. Subject to the Commission's approval and completion of pricing and reimbursement discussions, Novo Nordisk expects to launch Xultophy in the first European markets in the first half of 2015.