ANX007 for geographic atrophy receives priority medicine designation from EMA
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Key takeaways:
- The European Medicines Agency granted priority medicine designation to ANX007.
- The designation is supported by positive results from the phase 2 ARCHER trial in geographic atrophy.
The European Medicines Agency granted priority medicine designation to ANX007 for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release from Annexon Biosciences.
“PRIME designation for ANX007 is an important and exciting step for the entire field of ophthalmology retina specialists,” Douglas Love, president and CEO of Annexon, told Healio. “The designation represents external regulatory validation of both the unmet medical need for geographic atrophy that the field well recognizes and, more specifically, the strength of the data from the ARCHER trial that was the first to demonstrate a durable and dose-dependent potential benefit for patients by preserving visual function.”
ANX007 is a Fab antibody designed to selectively inhibit C1q to treat neurodegeneration. It showed efficacy in protecting against photoreceptor damage as well as visual function preservation in the phase 2 ARCHER trial.
The EMA grants PRIME designation to “optimize development plans and speed up evaluations” for certain medicines to address significant unmet medical needs faster, according to the release.
“The PRIME designation of ANX007 highlights new possibilities for the treatment of GA — that is, potentially providing preservation of vision for millions of patients impacted by the disease,” Love told Healio. “Next steps for the program include partnering with U.S. and EU regulatory authorities to optimally design and execute a global pivotal phase 3 program for ANX007.”
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