Risankizumab, Andexanet Alfa & GSK’s IV Zanamivir Up For CHMP Opinion
Opinions on whether new products for the treatment of conditions such as psoriasis, coagulation reversal, flu and diabetes should be granted an EU marketing authorization are due this week as the EMA’s key scientific committee, the CHMP, meets for the last time in London..
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Marketing applications for Teva’s migraine prevention CGRP inhibitor, fremanezumab, and CTI BioPharma’s myelofibrosis treatment, pacritinib, are among a number of submissions scheduled for discussion this week by the European Medicines Agency’s drug evaluation committee, the CHMP.
Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.