Apellis’ GA Drug Syfovre Displays Signs of Recovery Amid Challenges

Apellis' GA Drug Syfovre Displays Signs of Recovery Amid Challenges

Apellis Pharmaceuticals, which recently faced workforce reductions due to concerns surrounding its groundbreaking geographic atrophy (GA) drug, Syfovre, is reporting progress in reinvigorating the drug’s launch. The company estimated third-quarter sales of approximately $74 million for Syfovre, with demand picking up as doctors gain a better understanding of the risks associated with vascular retinitis, a vision-threatening inflammation disorder linked to the treatment.

During its initial full quarter on the market, Syfovre achieved sales of $67.3 million. However, in mid-July, the American Society of Retinal Specialists issued a letter to physicians, referencing six reports of occlusive retinal vasculitis among users of the injected therapy.

Apellis has now reported a total of 10 confirmed cases of retinal vasculitis, translating to a 0.012% chance per injection. Analysts at Evercore ISI noted three new potential cases since Apellis’ last update on August 22. It’s important to highlight these new cases, especially as some patients receive multiple injections of Syfovre, which is administered every two months.

Also Read: FDA Approves Izervay For Geographic Atrophy

Evercore analysts also observed an increased weekly shipment rate of Syfovre vials, averaging 3,581 since August 22, compared to the first three weeks of August, which averaged 2,917. This suggests that doctors may be moving past the concerns raised by the vasculitis incidents in July.

Syfovre, approved in February, marked a significant milestone as the first treatment for GA, an advanced form of age-related macular degeneration and a leading cause of blindness. However, in August, Astellas gained approval for its GA treatment, Izervay. While Astellas reported positive results from a phase 3 trial, it provided limited details about the data, leaving questions about its effectiveness.

Also Read: Astellas Claims Positive Results For Izervay In Geographic Atrophy But Remains Vague On Data

β€œIn only seven months, more than 100,000 vials have been shipped to physician practices, which we believe is a testament to the unmet need and the strength of Syfovre ’s product profile. Syfovre offers increasing treatment effects over time with as few as six doses per year. It is very encouraging to see the return to weekly growth in demand as physicians and patients have learned more about the long-term efficacy from the GALE study and real-world safety of Syfovre. With our permanent J-code now in place, we look forward to building on these trends and continuing to bring Syfovre to people living with this chronic disease.”

– Adam Townsend, chief commercial officer, Apellis

With approximately 1.5 million people affected by GA in the United States, the stakes are high. Prior to the reports of retinal vasculitis, analysts had estimated peak sales potential for Syfovre at $3 billion. These developments underscore the challenges and opportunities in the field of ophthalmic medicine, particularly in addressing vision-threatening conditions like GA.

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