Yes For Shionogi But No For Lilly In Latest EMA Recommendations
The European Medicines Agency says that Shionogi’s novel antibiotic, Fetcroja, should be approved for use across Europe but that Lilly's migraine drug, Emgality, should not be authorized for the extended indication of episodic cluster headache.
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This is an 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.
The company believes the PD-1 inhibitor’s recent declines will be reversed through new indications, providing revenue growth along with other new products by the time Revlimid faces generics in 2022.
The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.