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EMA Backs EU Approval For Ztalmy & Pylclari Roche Withdraws EU Filing For AMD Implant

 
• By Neena Brizmohun

Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.

Ztalmy (ganaxolone), Marinus Pharmaceuticals' treatment for epileptic seizures associated with a certain genetic disorder, and Curium's diagnostic agent for prostate cancer, Pylclari (piflufolastat (18F)), should both be approved for use in the EU, the European Medicines Agency‘s human medicines committee, the CHMP, said this week.

The CHMP recommended that Ztalmy be approved for treating epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients two to 17 years of age, and said

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