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Rydapt set for EU approval after Novartis addresses CHMP concerns

 
• By Maureen Kenny

Novartis’s new kinase inhibitor, Rydapt (midostaurin), for the treatment of AML and mastocytosis, could have got the thumbs up for EU approval in June but the committee that makes the decision, the European Medicines Agency’s CHMP, had concerns about the application. The CHMP has now issued a positive opinion for the orphan drug and formal EU approval is in sight.

Targets hit in the center by arrows
Rydapt would be first targeted treatment in the EU for certain AML patients • Source: Shutterstock

Novartis’s Rydapt (midostaurin) is set for approval in the EU for the treatment of acute myeloid leukemia and for the treatment of systemic mastocytosis after the company addressed outstanding concerns the European Medicines Agency’s key advisory committee, the CHMP, had with the marketing authorization application for the new immunotherapy.

The CHMP gave Rydapt a positive opinion at its July plenary meeting last week. (Also see "EU Marketing Approval In Sight For 11 Drugs After CHMP OK;...

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