The FDA has named the first nine medications selected for its national priority review voucher program, which aims to shorten drug review timelines to as fast as two months, according to an Oct. 16 episode of an FDA podcast.
The program, led by Mallika Mundkur, MD, chief medical officer of the FDA, is designed to accelerate reviews for therapies that address significant national priorities, such as unmet public health needs, domestic manufacturing priorities and affordability.
Among the selected drugs is Cytisinicline, a candidate for vaping cessation, a condition affecting approximately 46 million Americans who use tobacco or nicotine products. Another, DB-OTO, is a gene therapy for congenital deafness that recently showed improved hearing in 67% of treated children, with three achieving normal sensitivity.
Other selected drugs include Teplizumab for Type 1 diabetes, a KRAS inhibitor for pancreatic cancer, and Bitopertin for erythropoietic protoporphyria, a rare condition also referred to as “vampire syndrome.” The program also selected ketamine and Augmentin, both tied to efforts to strengthen domestic manufacturing. Pergoveris, a treatment for infertility in women undergoing IVF, and Cenegermin, a nerve growth factor for vision loss due to nonarteritic anterior ischemic optic neuropathy, were also included.
This initial group of selected therapies represents the program’s early efforts to reduce idle time in the drug review process while upholding safety and scientific rigor.
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