Astellas and Europe Clash Over Approval of Geographic Atrophy Drug Izervay

Izervay by Astellas and Syfovre by Apellis are the major rivals in the United States Geographic Atrophy (GA) market, but both are struggling to enter the European market. Due to EMA’s CHMP second negative decision on Apellis’ Syfovre, Astellas has decided to withdraw its Izervay approval application, primarily due to the continental regulator conversations.

Nevertheless, today Astellas reiterated its confidence in the efficacy of Izervay as a GA therapy and reiterated its determination to move forward with its submission to different world regulatory agencies, including the EMA, for the treatment of this population.
This development is a blow to Astellas, which paid $5.9B to acquire Iveric Bio, the company behind the complement C5 inhibitor Izervay. Marci English, Astellas’ Vice President and head of BioPharma and Ophthalmology Development said that the company was disappointed by CHMP’s response, but reiterated the company’s willingness to contribute to meet patient needs globally, citing the benefit of Izervay to GA patients in the U.S.
Astellas has not elucidated the CHMP’s specific concerns with Izervay either but it only elaborated that the agency had some reviews. However, when the CHMP turned down Syfovre in June over non-approval, it argued that while the treatment puts on brake on the GA lesion progression, it did not provide much clinical benefits to the patients. Apellis intends to apply for a retrial in the first place; the final decision would be made in the fourth quarter of the current year.
Having received approval in the United States in February of 2023 Syfovre encountered the initial hitches trailing reports of retinal vasculitis, a severe inflammatory condition documented by ASRS. It has since, though, and just posted second-quarter US sales of $156M, with third-quarter results expected soon. On the other hand, Astellas said in the increase, the company recorded August quarterly sales for Izervay of about 127B yen ($833M), which is more than expected.

Izervay is an FDA-approved tablet used in patients with AGHD that was first approved in August 2022; the warnings on the label are endophthalmitis, infections as well as increased intraocular pressure. The treatment, which was given as a 2 mg intravitreal injection monthly, has been approved from two phase 3 trials, showing a delay of up to 35% of the progression of GA for 12 months against a control.
By the current position, Astellas and Apellis will take up the US market without a significant competitor; however, Roche and AstraZeneca have also created GA therapies in phase 2. The late stage of dry AMD, also called geographic atrophy, results in a significant loss of vision.

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