FDA Accelerates Again: The Second CNPV Cohort

FDA is moving with notable speed.  Less than a month after announcing its inaugural class of Commissioner’s National Priority Voucher (CNPV) winners (see our previous post), the agency has already named its second cohort.

The CNPV program, designed to accelerate the review of products that advance key national priorities, from improving affordability to addressing unmet public health needs, has captured the attention of industry.  While we have yet to see a voucher’s effect on a review timeline, a voucher may materially change a product’s path to market.

Announced on November 6, the six new awardees reflect some of the most closely watched products in development today, spanning gene editing, oncology, metabolic disease, and global public health.  Five of the six products selected are already approved for at least one indication.  While the basis for some of the selections is clear, others are less clear.  For two of the products (Wegovy and orforglipron, both identified as “for obesity and related health conditions”), their selection was concurrent with pricing agreements, including Most-Favored-Nation (MFN) pricing agreements:

• Wegovy (semaglutide) – Since Wegovy’s initial approval in 2021 for chronic weight management, Wegovy’s labeling has expanded to include adolescents (2022), cardiovascular risk reduction (March 2024), and non-cirrhotic MASH (August 2025). Its selection likely reflects alignment with the CNPV program’s affordability and national health priority goals – potentially tied to the forthcoming 25 mg oral formulation and recently announced pricing commitments for GLP-1s.
• Orforglipron – As the only non-approved product on the list, orforglipron is a once-daily, oral, non-peptide GLP-1 receptor agonist, which would be positioned to offer a more accessible alternative to injectable GLP-1 therapies, if approved. Its inclusion signals FDA’s recognition of obesity as a national health priority, and the selection comes in the context of Eli Lilly’s recent drug-pricing announcement, aligning with the CNPV program’s goals of improving affordability and patient access.

The remaining four products selected for vouchers appear to be for potential expansions of existing indications or new indications:

• Casgevy (exagamglogene autotemcel) – Casgevy was approved by the FDA in December 2023 as the first FDA-approved CRISPR-based gene-editing therapy for patients ≥12 years with Sickle Cell Disease. Ongoing clinical development may further expand its use to younger patients (ages 5-11).
• Jemperli (dostarlimab-gxly) – Although Jemperli was already approved for certain endometrial cancer indications beginning in 2021, the product’s December 2024 Breakthrough Therapy Designation for locally advanced mismatch repair deficiency (dMMR)/microsatellite instability-high (MSI-H) rectal cancer was likely a key driver. Data to date showing a 100% clinical complete response rate suggest a potential shift in the treatment paradigm.
• Hernexeos (zongertinib) – Hernexeos was granted accelerated approval in August 2025 as a second-line, first-in-class oral HER2-directed tyrosine kinase inhibitor for HER2-mutated NSCLC. Hernexeos has provided a targeted option for a population with historically limited choices and poorer outcomes.  Ongoing Phase 3 development is evaluating Hernexeos as a first-line therapy in combination with Keytruda, with preliminary data expected late next year.
• Sirturo (bedaquiline) – Sirturo was initially granted accelerated approval in 2012 for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults, followed by traditional approval in July 2024 with expanded use in pediatric patients > 2 years of age. The voucher is identified as being for “drug-resistant tuberculosis in young children.”  It is not clear what expansion to the labeling is anticipated.

This second CNPV cohort reinforces that FDA intends to deploy this program to reward products that are in line with the Commissioner’s priorities.  We will be watching to see how these vouchers play out.