The Apellis Pharmaceuticals restructuring will save up to $300 million. It comes as the biotech continues its inquiry into the cause of a rare inflammatory complication reported in a small number of patients who received its geographic atrophy drug, Syfovre.
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Astellas Pharma is acquiring Iveric Bio in a deal that brings a vision loss-disorder drug on track for an FDA decision this summer. Iveric’s pipeline also includes genetic medicines that fit Astellas’s gene therapy strategy.
The FDA approved Apellis Pharmaceuticals’ Syfovre as a treatment for geographic atrophy, a retinal disorder that is a leading cause of blindness. The drug, administered as an injection into the eye, will launch in March at the price of $2,190 per vial.
Geographic atrophy has no FDA-approved treatments, and Merck is walking away from its contender in the chase for one. The pharmaceutical giant declined to exercise its option on several NGM Biopharmaceuticals eye programs, a decision that follows a Phase 2 clinical trial failure.
NGM Biosciences’ experimental geographic atrophy therapy failed a mid-stage test, making it less likely that drug partner Merck will exercise its option on the antibody. Meanwhile, an Apellis Pharmaceuticals drug for the same disorder is expected to receive an FDA decision by late November.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Apellis Pharmaceuticals has additional clinical data that show its drug having an effect on geographic atrophy, a rare vision-loss disorder with no FDA-approved treatment. The biotech plans to include the latest results in a new drug application being readied for submission in coming months.