Astellas and Apellis are two companies competing in the U.S. to treat geographic atrophy (GA), a serious eye condition that can lead to vision loss. However, they are facing challenges in getting their treatments approved in Europe.
Astellas recently withdrew its request to approve its drug, Izervay, in Europe after discussions with European regulators, although they still believe in its effectiveness. This is a setback for Astellas, especially after they spent $5.9 billion to acquire the company that developed Izervay. Despite this, Astellas is committed to making Izervay available worldwide.
Apellis also faced a setback when the European Committee for Medicinal Products for Human Use (CHMP) rejected their drug, Syfovre, for the second time. The CHMP said Syfovre did not provide significant benefits to patients. Apellis plans to challenge this decision.
In the U.S., both drugs are approved and have been on the market. Syfovre had some initial challenges due to reports of eye inflammation but has since recovered with strong sales. Izervay also showed positive sales figures and is administered monthly to slow disease progression.
Both companies have the U.S. market largely to themselves for now, as other competitors like Roche and AstraZeneca are still in earlier testing phases for their GA treatments. GA affects many people, often leading to severe vision loss, and many cases remain undiagnosed.