Decision Time At CHMP: Portola and Aegerion In Spotlight

21 Feb 2018

• By Maureen Kenny

Nine marketing authorization applications, 15 variation of therapeutic indication requests, two requests for accelerated assessment and a re-examination procedure. These are some of items on the agenda at the latest meeting of the EMA’s key advisory panel, the CHMP, which is under way in London.

Milestone — A green light from the CHMP is a huge milestone for companies • Source: Shutterstock

The European Medicines Agency’s key advisory committee, the CHMP, has been considering this week whether or not to recommend for approval across the EU a clutch of new products, including AndexXa (andexanet alfa), Portola Pharmaceuticals’ potential Factor Xa anticoagulant reversal agent, and Myalepta (metreleptin), Aegerion Pharmaceuticals’ orphan-designated drug for leptin deficiency in patients with lipodystrophy.

Both Portola and Aegerion appeared before the CHMP in an effort to address outstanding concerns the panel had with their...