The FDA has extended the review period for Optinose’s sNDA seeking approval of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps, Optinose said. Xhance was originally approved by the FDA in 2017 for the treatment of nasal polyps. The agency originally accepted the sNDA in May 2023 and set a PDUFA goal date of December 16, 2023. The new PDUFA goal date is March 16, 2024.
According to Optinose, the FDA requested additional efficacy subset analyses of data related to from the Phase 3 ReOpen1 trial on November 15, 2023; the company submitted those analyses on November 22, 2023; and the agency informed the company of the extension of the review period on December 4. Optinose reports that “The additional efficacy subset analyses requested by the FDA evaluated the subgroup of patients in ReOpen1 consisting of patients without nasal polyps plus those patients with a nasal polyp grade of one or less at trial entry.”
Optinose CEO Ramy Mahmoud commented, “We believe the ReOpen trials demonstrated important clinical benefits Xhance could offer chronic sinusitis patients and, if approved, we look forward to providing doctors and their patients the first-ever medication to treat all chronic sinusitis patients, including those with or without nasal polyps.”
Read the Optinose press release.
