European CHMP Opinions And MAA Updates
Executive Summary
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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EU's CHMP OKs Major New Uses for Hemlibra, Praluent, Forxiga – And More
Several major products have been recommended for wider indications in the EU, including Roche’s hemophilia drug Hemlibra, Sanofi’s Praluent in atherosclerotic disease, and AstraZeneca’s Forxiga for type 1 diabetes.
Teva’s Ajovy & Pfizer’s Vizimpro Get EU Thumbs Up From CHMP
The European Medicines Agency’s drug evaluation committee has recommended for approval Teva’s Ajovy for migraine and Pfizer’s Vizimpro for NSCLC, as well as two more biosimilar versions of adalimumab (AbbVie’s Humira) and generics of atazanavir and feboxustat.
Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab
Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.