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Isatuximab EU Approval Decision Due

Sanofi Product Is On List of Hopefuls At CHMP Meeting

 
• By Maureen Kenny, Francesca Bruce, Ian Schofield, and Dave Wallace

Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.

A number of products at the final stages of review at the European Medicines Agency are finding out this week whether they have cleared a critical milestone in their journey to the EU market. They include Sanofi Aventis’s isatuximab for multiple myeloma, two indacaterol acetate and mometasone furoate combinations for the treatment of asthma from Novartis, and pretomanid, a new antibacterial for treating tuberculosis from the TB Alliance.

The March meeting of the EMA’s drug evaluation committee, the CHMP, has been taking place and marketing authorization applications (MAAs) for these products are listed as being up for an...

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