By Patrick Wingrove and Dan Levine
Dec 17 (Reuters) – The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with multibillion-dollar potential, according to internal documents seen by Reuters.
Merck’s cholesterol pill enlicitide decanoate and its cancer therapy sacituzumab tirumotecan, or sac-TMT, have been tapped for the Commissioner’s National Priority Voucher program, potentially making them the 17th and 18th medicines included in the new program, documents show.
The FDA expects Merck to submit its applications for enlicitide in April and for sac-TMT in October or November next year, according to one document.
Launched in June, the voucher program aims to speed FDA decisions for drugs with critical public health or national security impact, promising one- to two-month reviews versus the usual 10 to 12 months.
For Eli Lilly’s weight-loss pill evaluation, reviewers set a six-month total timeline under the program, which FDA leaders were pushing to cut by up to seven weeks.
Several priority review vouchers, including Lilly’s, were awarded as part of deals with the Trump administration to lower the prices of prescription medicines for government programs and cash-paying patients. Other drug candidates were invited to participate.
A spokesperson for the Department of Health and Human Services, which oversees the FDA, said until there is an official announcement from the agency, this report is speculation. It said, however, the voucher program “strengthens FDA’s ability to accelerate development of products that meet urgent public health needs.”
Merck declined to comment.
CLINICAL TRIALS AND BIG SALES POTENTIAL
In a late-stage, 24-week trial, enlicitide significantly cut levels of LDL cholesterol compared with a placebo in patients with hypercholesterolemia, Merck said in September. Those with the condition, marked by severely elevated LDL levels, are considered high risk for heart attack and stroke.
At a major medical meeting last month, the company said it expects enlicitide, which could be the first oral PCSK9 inhibitor on the market, to achieve multibillion-dollar peak annual sales. The drug would compete with injectable PCSK9 drugs like Amgen’s Repatha.
In November, Merck also announced a $700 million funding deal with Blackstone Life Sciences to develop sac-TMT, which the company has been testing against different tumor types, including breast, endometrial and lung cancers.
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 tissue than chemotherapy.
Jefferies analysts, in a note to clients, said the Blackstone deal indicated the potential for peak annual sac-TMT sales of more than $10 billion.
Merck has been working to advance its pipeline and launch new drugs before its blockbuster cancer therapy Keytruda, the world’s top-selling drug with nearly $30 billion in annual sales, faces competition from cheaper biosimilars later this decade.
The FDA earlier this week issued its 16th National Priority Review voucher to Johnson & Johnson for its new blood cancer treatment Tecvayli in combination with Darzalex.
(Reporting by Patrick Wingrove in New York and Dan Levine in San Francisco; Editing by Caroline Humer and Bill Berkrot)
