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Annexon Receives PRIME Designation from the EMA for ANX007 for the Treatment of Geographic Atrophy
PRIME Designation Granted Based on Phase 2 ARCHER Trial Results, which Showed Meaningful Preservation of Visual Function in Patients with Geographic Atrophy
About this update from Annexon, Inc.
[{"type":"text","content":"PRIME Designation Granted Based on Phase 2 ARCHER Trial Results, which Showed Meaningful Preservation of Visual Function in Patients with Geographic Atrophy ANX007 is the First Therapeutic Candidate to Receive PRIME Designation by the EMA for the Indication of Geographic Atrophy Company Engaging with U.S. and EU Regulatory Authorities to Determine the Optimal Global Pivotal Phase 3 Program for ANX007 BRISBANE, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX) a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to ANX007 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The EMA granted this designation, which provides enhanced development support for priority medicines that target an unmet need, based on the Phase 2 ARCHER trial data that showed a statistically significant, durable, and dose-dependent preservation of visual function in patients with GA, as well as preclinical data supporting the protective effect of ANX007 against photoreceptor damage. “GA is a progressive disease impacting millions of elderly people worldwide, which severely limits their independence. There is a need for a treatment that provides the benefit both patients and physicians most desire —preservation of vision,” said Douglas Love, president and CEO of Annexon. “The data from our Phase 2 ARCHER trial were the first to show a durable and dose-dependent preservation of visual function across multiple measures, including a statistically significant impact on the best corrected visual acuity (BCVA) functional endpoint. We believe PRIME designation supports the potential for ANX007 to address this critical need. As we look ahead, our focus remains on engaging with U.S. and EU regulatory authorities to optimally design and expedite a global pivotal Phase 3 program for ANX007 and bring this novel treatment to patients as quickly as possible.” The EMA’s PRIME designation provides early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or benefit to patients withou...