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Decision Time At CHMP: Portola and Aegerion In Spotlight

 
• 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 respective marketing authorizations applications (MAAs). Also see "Bumper Number...

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