What's Happening?
MSD, known as Merck & Co in the U.S., is reportedly set to receive two Commissioner's National Priority Vouchers (CNPVs) from the FDA for its oral PCSK9 inhibitor enlicitide decanoate and cancer therapy
sacituzumab tirumotecan. These vouchers are part of a program designed to expedite the review of important new therapies. Enlicitide offers an oral alternative to injectable PCSK9 inhibitors, while sacituzumab tirumotecan is a TROP2-directed antibody-drug conjugate for cancer treatment.
Why It's Important?
The awarding of CNPVs to MSD underscores the potential impact of these therapies on public health. Enlicitide could provide a more convenient treatment option for patients with high cholesterol, while sacituzumab tirumotecan could enhance cancer treatment options. The expedited review process aims to bring these therapies to market more quickly, potentially improving patient outcomes and addressing unmet medical needs.
What's Next?
MSD is expected to submit marketing applications for enlicitide in April and for sacituzumab tirumotecan later in the year. The success of these applications could lead to the availability of new treatment options for patients with high cholesterol and certain cancers. The CNPV program's impact on drug pricing and accessibility will also be closely monitored.
