Santen Oy’s Ryjunea (atropine) hybrid product for slowing the progression of myopia along with three biosimilar products have also drawn a thumbs up from the European Medicines Agency. Meanwhile, Eli Lily’s Kinsula (donanemab) was rejected amid safety concerns.
EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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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 EU, and updates on EU marketing authorization changes recommended by the CHMP.