FDA Approves Extended Use of Astellas’ IZERVAY for Geographic Atrophy

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FDA Approves Extended Use of Astellas’ IZERVAY for Geographic Atrophy

Astellas Pharma ( (JP:4503) ) has shared an announcement.

Astellas Pharma announced the FDA’s approval of an expanded label for IZERVAY™ for geographic atrophy secondary to AMD, allowing dosing beyond 12 months. The decision is based on positive results from the GATHER2 Phase 3 trial, which show IZERVAY’s efficacy in slowing GA progression. This approval strengthens IZERVAY’s market position, with significant distribution growth since 2023, and reaffirms its safety profile. The impact on Astellas’ financials for the fiscal year ending March 31, 2025, is expected to be minor.

More about Astellas Pharma

Astellas Pharma Inc. is a pharmaceutical company involved in the biopharma and ophthalmology sectors, focusing on innovative treatments for medical conditions such as age-related macular degeneration (AMD).

YTD Price Performance: -2.74%

Average Trading Volume: 5,670

Technical Sentiment Consensus Rating: Buy

Current Market Cap: $17.05B

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