US FDA reveals recipients of coveted national priority vouchers
On October 16, the U.S. Food and Drug Administration (FDA) revealed the beneficiaries of its new National Priority Voucher pilot program.
Key Beneficiaries of the Fast-Track Review Process
Nine products have been shortlisted for an expedited evaluation that significantly reduces the traditional 10-12 month review period to just one or two months.
Highlighted Products
- Merck KGaA’s fertility drug, Pergoveris
- Sanofi’s Type 1 diabetes drug, teplizumab
- Regeneron’s treatment for deafness, DB-OTO
- Domestically manufactured ketamine for use as a general anesthetic
- Revolution Medicines’ treatment for pancreatic cancer, RMC-6236
- Disc Medicine’s bitopertin for porphyria
- Achieve Life Sciences’ cytisinicline targeting nicotine vaping addiction
- Dompé’s blindness treatment, cenegermin-bkbj
- Augmentin XR, an antibiotic for domestic production
Following the announcement, there was noticeable market activity. Revolution’s shares increased by 7.4%, while Disc Medicine saw a 19% rise.
Background and Expectations
The National Priority Voucher program aims to focus on addressing significant national concerns, such as unmet medical needs and public health crises.
In June, the FDA launched this initiative, proposing a collaborative review method involving experts from various departments. This departs from the standard multi-office review approach.
Each drug review division within the FDA has been tasked with recommending a product, while external companies may also apply for evaluation. More products are anticipated to be announced in this program shortly.
Industry Reactions and Potential Additions
While Eli Lilly’s weight-loss pill, orforglipron, was speculated to be included through this fast-track process, it was not part of the recent announcement. The company expressed optimism about the program but indicated a need for further details.
The allocation of these national priority vouchers demonstrates a commitment to advancing treatments that address pressing healthcare challenges efficiently. Emegypt continues to follow this evolving story, promising to provide updates on forthcoming FDA decisions.
