CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

12 Oct 2017

• By Maureen Kenny

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will likely shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

EMA — The October meeting of the European Mediciines Agency's CHMP is taking place this week • Source: Shutterstock

Around ten companies whose products are at the later stages of evaluation at the European Medicines Agency will find out soon whether the agency has remaining concerns with their marketing authorization applications. The products include Ariad’s targeted kinase inhibitor, Alunbrig (brigatinib), and Portola’s Factor Xa anticoagulant, Bevyxxa (betrixaban).

One of the many things the EMA’s Committee for Medicinal Products for Human Use does at its monthly meetings with...