US FDA grants priority vouchers to Merck’s cholesterol pill, cancer therapy

Dec 19 (Reuters) – The U.S. Food and Drug Administration said on Friday it has granted national priority vouchers to Merck’s cholesterol pill and its cancer therapy, making them the latest additions to the fast-track program.

Reuters exclusively reported on Thursday that Merck’s drugs were the 17th and 18th medicines to be included in the FDA Commissioner’s National Priority Voucher program, since its launch in June.

The program cuts the review timeline of drugs considered critical to public health or national security needs to just one to two months from the usual 10-12 months.

Earlier this week, the FDA awarded the voucher to Johnson & Johnson’s blood cancer treatment, Tecvayli, in combination with Darzalex.

In a 24-week late-stage study, Merck’s pill Enlicitide meaningfully reduced LDL cholestrol levels in the blood, compared with a placebo, in patients with hypercholesterolemia, a condition that leads to plaque buildup in the arteries.

The condition, which lead to increased risk of heart disease, affects about 73.5 million Americans, according to government data.

Enlicitide works by blocking PCSK9, a protein that plays a crucial role in regulating cholesterol levels. Merck’s pill aims to compete with injectable PCSK9 treatments like Amgen’s Repatha.

Merck’s cancer therapy, sac-TMT, like other antibody-drug conjugates, is designed to deliver an anti-cancer drug more precisely to malignant cells, causing less damage to healthy tissues than chemotherapy.

Last month, Merck entered into a $700 million funding deal with Blackstone Life Sciences to develop sac-TMT.

Merck has been testing the therapy against different tumor types such as breast, endometrial and lung cancers.

Sac-TMT is being developed as part of an exclusive license and collaboration agreement with China’s Sichuan Kelun-Biotech Biopharmaceutical.

(Reporting by Siddhi Mahatole, Mariam Sunny and Sahil Pandey in Bengaluru; Editing by Leroy Leo and Shailesh Kuber)