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GA is a devastating disease that causes blindness, pegcetacoplan will bring the first treatment for GA patients
Recently, Apellis Pharma announced that it has received formal written feedback from the U.
In written feedback, the FDA stated that if clinical trials are adequate and well-controlled, the agency will not distinguish between different phases of the trial, and all three studies appear to be adequate and well-controlled
GA is an advanced type of age-related macular degeneration (AMD), and AMD is the leading cause of blindness
Pegcetacoplan is a targeted C3 inhibitor designed to regulate the excessive activation of the complement cascade
In May 2021, Empaveli (pegcetacoplan) was approved by the US FDA for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
It is worth mentioning that Empaveli is the first and only C3 targeted therapy that has received regulatory approval.
In the past decade or so, the only option for the treatment of PNH was C5 inhibitors, but many patients still experience persistent hypohemoglobinosis, which often leads to debilitating fatigue and frequent blood transfusions
