EU Marketing Approval In Sight For 11 Drugs After CHMP OK; Thumbs Down For Two
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received a negative opinion from the committee and the marketing authorization application for one product has been withdrawn.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.
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The EMA’s CHMP is this week hearing oral evidence on two products it turned down in July – for schizophrenia and metastatic breast cancer – as well as on other drugs for multiple myeloma and multiple sclerosis.
The two products that the European Medicines Agency’s key scientific committee, the CHMP, decided last week should not be approved in the EU were Vanda’s schizophrenia treatment Fanaptum (iloperidone), and Onzeald (etirinotecan pegol), a potentially new treatment for breast cancer with brain metastases from Nektar/Daiichi Sankyo Europe. The companies want the CHMP to look again at the negative opinions they received.
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.