One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another
Kyowa Kirin And Sanofi Want CHMP To Re-Examine Earlier Opinion About Their Products
Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.
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A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
A complete response letter from the FDA has dashed Sesen Bio’s hopes of being first with a therapy for treating BCG-unresponsive non-muscle invasive bladder cancer. Its CEO says the FDA’s move may reflect heightened ‘pressure’ regulator is under.
Sanofi wants the European Medicines Agency to re-examine its opinion that the company’s drug for Pompe disease does not qualify as a new active substance.