CHMP issues a positive opinion recommending full approval of Pepaxti in EU for patients with triple class refractory multiple myeloma.- Oncopeptides AB
Oncopeptides AB (publ) announces that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), has unanimously adopted a positive opinion recommending a full marketing authorization approval (MAA) of Pepaxti (melphalan flufenamide, also called melflufen) in EU.
The European Commission (EC) will make a legally binding decision based on the EMA recommendation within 60 days. Once granted by EC, the marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway.
The positive opinion is based on data from the phase II HORIZON study and is supported by data from the randomized controlled phase III OCEAN study which was utilized as confirmatory study. No specific post-marketing commitments were issued. Oncopeptides intends to submit a type II variation in Q4 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM).
Oncopeptides will advance market access activities after an approval by the European Commission, to pave the way for a successful launch of Pepaxti in Germany in Q4, 2022..
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