Apellis, Pegcetacoplan and Geographic Atrophy
Europe's CHMP turns down Apellis' pegcetacoplan appeal, endorses new drugs from Pfizer, ImmunoGen and Henlius
Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been left in the cold once again. | Europe’s Committee for Medicinal Products for Human Use has confirmed its negative stance on pegcetacoplan in geographic atrophy,
Apellis Says CHMP Confirms Negative Opinion For Pegcetacoplan In Geographic Atrophy, Stock Down
Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
“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.”
Apellis Pharmaceuticals declines afters CHMP's third negative opinion on Syfovre
European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for its eye disease therapy for the third time this year. Apellis reported that the Committee for Medicinal Products for Human Use,
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
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.” “We have seen the profound impact this medicine has had for GA patients in the U.
Medscape1d
Study Indicates Who May Benefit Most From GA Treatment
A real-world study of pegcetacoplan for treatment of geographic atrophy showed significantly better outcomes than the pivotal clinical trials in patients who had symptomatic vision loss.
Zacks.com on MSN1d
Apellis Stock Down as Eye Drug Faces Third CHMP Rejection in the EU
Apellis Pharmaceuticals APLS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European ...
What's Going With Apellis Pharmaceuticals Stock Friday?
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) shares are moving lower Friday after the Committee for Medicinal Products for ...
Medscape4d
Two New Drugs Approved for Age-Related Macular Degeneration
The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its ...
The American Journal of Managed Care28d
Pegcetacoplan May Reduce Fatigue in PNH Accompanied by Anemia
Findings from a post hoc analysis of 3 clinical trials support the switching to or initiation of pegcetacoplan to manage fatigue for patients with paroxysmal nocturnal hemoglobinuria (PNH ...
Pharmaceutical Technology on MSN11d
Sobi and Enable Injections partner for Aspaveli distribution
Sobi and Enable Injections have entered an agreement for the development and distribution of Aspaveli in combination with ...
Apellis eye drug again turned back in Europe
The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple ...