News

Oct 29, 2024

Astellas pulls application for Izervay after talks with CHMP

While Astellas’ Izervay and Apellis’ Syfovre battle for market share in geographic atrophy (GA) in the United States, both companies are struggling to reach patients in the indication in Europe. Four

While Astellas’ Izervay and Apellis’ Syfovre battle for market share in geographic atrophy (GA) in the United States, both companies are struggling to reach patients in the indication in Europe.

Four months after the Committee for Medicinal Products for Human Use (CHMP) rejected Apellis’ GA application for Syfovre for a second time, Astellas has withdrawn its application for the approval of Izervay based on discussions with the European regulator.

In a release, the Japanese company said it “remains confident” in Izervay’s clinical benefit and will continue to engage with regulators around the world, including those from the European Medicines Agency (EMA), to bring the treatment to patients with GA.

The detour for Izervay is a significant blow for Astellas, which paid $5.9 billion to acquire Iveric Bio, the New Jersey-based company that developed the complement C5 inhibitor.

“While we are disappointed with the CHMP’s response, we have seen the impact this medicine has had for GA patients in the U.S. and remain committed to serving unmet patient needs globally,” Marci English, Astellas’ VP and head of BioPharma and Ophthalmology Development, said in a statement.

The company did not indicate what issues the CHMP had with Izervay.

In rejecting Apellis' Syfovre in June, the CHMP said that while the therapy slowed the growth of GA lesions, it “did not lead to clinically meaningful benefits for patients.” Apellis said then that it would seek a reexamination of the opinion, with a final decision expected in the fourth quarter of this year.

Shortly after Syfovre was approved in the U.S. in February of 2023, its launch was hindered by reports of an eye inflammation condition, retinal vasculitis, from the American Society of Retinal Specialists (ASRS). But Syfovre has recovered, with Apellis reporting second-quarter sales of $156 million. The company reveals third-quarter results next week.

Meanwhile, in August, Astellas reported quarterly sales of Izervay at 12.7 billion Japanese yen ($83 million), which the company said exceeded (PDF) expectations. The FDA approved Izervay in August of last year.

Izervay’s label also includes warnings about endophthalmitis (inflammation), infections and intraocular pressure. A 2 mg intravitreal dose of the drug is administered monthly. The drug was approved based on two phase 3 trials that showed that it slowed progression of the disease by up to 35% over 12 months compared to a control treatment.

Astellas and Apellis will likely have the market to themselves for the next few years. Roche and AstraZeneca have GA candidates in phase 2 for GA, which is an advanced form of dry age-related macular degeneration (AMD) that can progress quickly and lead to irreversible vision loss.

GA affects an estimated 1.5 million people in the U.S., but approximately three-quarters of people living with the condition are thought to be undiagnosed. Without treatment, an estimated 66% of people with GA may become blind or severely visually impaired.