Lebrikizumab Among Nine Drugs To Get EMA Nod; PTC Faces Disappointment For Translarna
The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs.
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EU marketing authorization applications have been submitted for a number of new drugs, including Eli Lilly’s donanemab, Italfarmaco's givinostat and Arcturus Therapeutics/CSL’s ARCT-154.
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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
The US FDA approved the JAK inhibitor momelotinib for myelofibrosis with anemia, with an analyst forecasting peak sales of more than $425m.