Rydapt set for EU approval after Novartis addresses CHMP concerns
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.
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Rydapt represents the first major development in targeted acute myeloid leukaemia treatment in more than 25 years as Novartis plots its commercial launch in Europe.
The European Medicines Agency’s key scientific committee, the CHMP, has recommended for approval throughout Europe a total of 11 new drugs. Two medicines received a negative opinion from the committee and the marketing authorization application for one product has been withdrawn. A further eight products are set to receive indication extensions. The medicines that got positive opinions are likely to secure official approval within the next few months.
Among products that are due for a go/no-go recommendation by the European Medicines Agency this week are new drugs for conditions such as cancer, multiple sclerosis, mastocytosis, HIV and hepatitis C.