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CHMP recommends Rhokiinsa approval in Europe
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for Rhokiinsa for the reduction of IOP in primary open-angle glaucoma or ocular hypertension, Aerie Pharmaceuticals announced in a press release.
Rhokiinsa (netarsudil ophthalmic solution 0.02%) is marketed as Rhopressa in the United States.
“We are delighted that the CHMP has adopted a positive opinion for Rhokiinsa,” Vicente Anido Jr., PhD, chairman and CEO at Aerie, said in the release. “We look forward to the European Commission’s final decision on the MAA for Rhokiinsa and, if approved, we plan to submit the MAA for Roclanda, marketed as Rocklatan in the United States, shortly thereafter.”
A final decision is expected in about 2 months and will apply to all European Union member states plus Iceland, Norway and Liechtenstein.