MSD claims two national priority vouchers; report

The next two discretionary priority vouchers to be awarded by the FDA are reported to be heading for two MSD candidates with blockbuster potential.

According to Reuters, MSD – known as Merck & Co in the US and Canada – is set to be the recipient of the 17th and 18th Commissioner's National Priority Vouchers (CNPVs) for oral PCSK9 inhibitor enlicitide decanoate, a cholesterol-lowering therapy, and new cancer therapy sacituzumab tirumotecan.

The CNPV programme was launched earlier this year and is designed to bring important new therapies to patients more quickly and plug gaps in the domestic supply of essential medicines, with FDA reviews in two months or less. However, questions have been raised about its legality and vulnerability to political influence.

According to the report, Reuters has seen internal FDA documents naming the two medicines as being in line for the programme, which saw its first approval – for a generic antibiotic product – earlier this month.

Enlicitide is an oral alternative to current injectable drugs in the PCSK9 inhibitor class and caused a stir at the recent AHA congress, with new data showing a near-60% reduction in LDL-cholesterol in patients with hypercholesterolaemia who cannot meet their treatment goals using standard statin therapy.

The CORALreef Lipids study, which enrolled around 2,900 people with or at risk of atherosclerotic cardiovascular disease (ASCVD), also showed significant reductions on a range of secondary risk markers for heart disease with MSD's drug.

Sacituzumab tirumotecan (also known as sac-TMT), meanwhile, is a TROP2-directed antibody-drug conjugate (ADC) that MSD licensed from Kelun-Biotech and is already approved in China for non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

MSD licensed the drug from Kelun in a $1.4 billion deal signed in 2022 and is testing the ADC in a wide range of solid tumours alone and in combination with its blockbuster PD-1 inhibitor Keytruda (pembrolizumab).

According to the documents seen by Reuters, the FDA is expecting MSD to submit marketing applications for enlicitide in April and for sac-TMT in October or November next year.

The news wire notes that several of the CNPVs have been awarded to companies that have agreed deals with the Trump administration to lower the prices of prescription medicines for government programmes – including the upcoming TrumpRx direct-to-consumer (DTC) channel – and cash-paying patients.

Earlier this week, Johnson & Johnson – which announced a $55 billion investment programme in the US earlier this year – was awarded the 16th CNPV for a combination regimen based on BCMAxCD3 bispecific Tecvayli (teclistamab) for multiple myeloma.