Catching up on recent approvals…….
The FDA recently approved a new intravitreal injection, Izervay (avacincaptad pegol intravitreal solution) from Iveric Bio (an Astellas company), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is approved for administration to each affected eye once monthly (approximately 28 ± 7 days) for up to 12 months by a qualified physician.
Izervay is now the second therapy approved to treat geographic atrophy. Its approval came less than three weeks after Apellis Pharmaceuticals’ competing product, Syfovre, was flagged for severe side effects.
Astellas announced that it will launch Izervay at $2,100 for a monthly dose which appears to shadow price its competitor, Syfovre. The company did not disclose plans for distribution or logistics. It is expected that the product will launch through specialty pharmacy distribution.
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Astellas wins FDA approval of eye disease drug Izervay and may have edge in market battle with Apellis
Aug 7, 2023 — The approval of Izervay for geographic atrophy may put Astellas in an advantageous position as it competes with another newly approved treatment in the indication, Apellis’ Syfovre. (Astellas)
Less than four months after Astellas’ $5.9 billion buyout of eye disease specialist Iveric Bio, the deal is already making the Tokyo-based company look visionary.
It adds up to a major commercial opportunity for Astellas and potentially a big score for its new CEO, Naoki Okamura, who has been tasked with charting the company’s course as it nears the 2027 patent cliff for lucrative cancer drug Xtandi. Last year the prostate cancer treatment generated $4.7 billion for Astellas, accounting for 44% of its revenue.
The approval of Izervay brings a new potential blockbuster. the article continues…………
