Pegcetacoplan receives negative opinion from European committee after reexamination
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The Committee for Medicinal Products for Human Use of the European Medicines Agency confirmed its negative opinion on the marketing authorization application for intravitreal pegcetacoplan for geographic atrophy.
As Healio previously reported, Apellis Pharmaceuticals received a negative opinion for the treatment in June and sought reexamination. The company remains committed to expanding access to pegcetacoplan despite the ruling, Cedric Francois, MD, PhD, CEO and co-founder of Apellis, said in a press release.
“We are deeply disappointed by this outcome, which leaves millions of Europeans with GA without a treatment for this irreversible form of blindness,” he said. “This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.”
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