The second batch of Commissioner’s national priority vouchers (CNPVs) has been published by the FDA, and includes new GLP-1 agonists for weight-loss from Eli Lilly and Novo Nordisk and drugs for cancer and rare diseases.
The scheme – first announced earlier this year – provides a fast track for medicines that are deemed to be of national priority and could deliver a decision on approval within one to two months.
The inclusion of Lilly’s oral GLP-1 orforglipron and a new filing for Novo Nordisk’s Wegovy (semaglutide) for obesity and related health conditions comes after the Trump administration signed agreements with the two companies to reduce the prices of their GLP-1-based drugs for obesity and diabetes, as well as other products, in return for Medicare and Medicaid coverage.
Under the terms of that deal, orforglipron will be priced at $149 per month via the upcoming TrumpRx direct-to-consumer (DTC) sales channel, which is expected to launch with pricing before the end of the year and start supplying medicines in January. Wegovy, meanwhile, is having its price reduced to $350 per month through the channel.
“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” said FDA Commissioner Marty Makary (pictured above).
The latest list gives few details about the specific indications, but adds six new medicines to the nine included in the first batch announced last month. Other than orforglipron, all the latest vouchers are for drugs that are already on the market, and at present the specific reasoning behind the awards is unclear, but likely relates to label extensions.
Drugs included in the CNPV scheme are selected based on external applications and internal nominations from FDA review divisions.
The latest additions include Boehringer Ingelheim’s oral HER2 inhibitor Hernexeos (zongertinib), which got a green light for previously-treated HER2-positive non-small cell lung cancer (NSCLC) in the summer, and GSK’s PD-1 inhibitor Jemperli (dostarlimab) – first launched in 2021 – for rectal cancer. At the moment, Jemperli is FDA-approved for endometrial cancer and solid tumours with dMMR/MSI-H mutations.
The final two in the latest update are Vertex Pharmaceuticals’ 2023-approved CRISPR-based gene therapy Casgevy (exagamglogene autotemcel) for sickle cell disease, and Johnson & Johnson’s anti-tuberculosis medicine Sirturo (bedaquiline), which was first cleared by the FDA over a decade ago.
Drugs included in the CNPV scheme are selected based on external applications and internal nominations from FDA review divisions.
