The Food and Drug Administration announced on Thursday the first round of experimental drugs to be included in a priority voucher program. This FDA initiative is designed to expedite drug review processes for products that align with critical U.S. national health priorities, reducing review times from 10 to 12 months to just one to two months.
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The new Commissioner's National Priority Voucher (CNPV) process accelerates the timeline by convening a multidisciplinary team of physicians and scientists for a team-based review, interacting frequently with the sponsor to clarify questions, and completing review of the application concurrently.
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Once all streamlined review steps are complete, the team will convene for a one-day "tumor board style" meeting.
If necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they deem appropriate.
The agency announced nine voucher recipients under the new CNPV pilot program, including potential treatments for vaping addiction, deafness, pancreatic cancer and other conditions, including:
EMD Serono’s, a unit of Merck KGaA (OTC:MKGAF) (OTC:MKKGY), Pergoveris for infertility.
Sanofi SA’s (NASDAQ:SNY) Teplizumab for Type I diabetes.
Achieve Life Sciences Inc.’s (NASDAQ:ACHV) cytisinicline for nicotine vaping addiction.
Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) DB-OTO for deafness.
Privately held- Dompé Farmaceutici S.p.A.’s Cenegermin-bkbj for blindness.
Revolution Medicines Inc.’s (NASDAQ:RVMD) daraxonrasib (RMC-6236) for pancreatic cancer. Daraxonrasib is being studied in two global Phase 3 clinical trials, RASolute 302 in patients with previously treated metastatic pancreatic ductal adenocarcinoma and RASolve 301 in patients with previously treated metastatic non-small cell lung cancer.
Disc Medicine Inc.’s (NASDAQ:IRON) Bitopertin for erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP). Disc is seeking accelerated approval of bitopertin for patients aged 12 years and older with EPP.
Ketamine for the domestic manufacturing of a general anesthetic.
Augmentin XR for domestic manufacturing of a common antibiotic.
Price Actions: IRON stock is up 24.93% at $92.90, ACHV stock is up 33.44% at $4.11, and RVMD stock is up 11.74% at $55.48 during the premarket session at the last check on Friday.
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