The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for review submitted by Regeneron Pharmaceuticals REGN and Sanofi SNY for the lead drug candidate Dupixent (dupilumab) for the treatment of patients with prurigo nodularis.
The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of Sept. 30, 2022.
The filing is supported by data readout from PRIME2 and PRIME pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis.
Prurigo nodularis is a chronic skin disease that causes extreme itch and inflammatory skin lesions (nodules).
The company said that additional regulatory filings around the world are also planned in 2022.
The FDA grants Priority Review that shortens review period of BLA, applicable for medicines which may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition.
Regeneron shares are trading down 4.14% at $664.12.
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