FDA Fast-Tracks Merck Drugs Boosting Billion-Dollar Breakthroughs

The FDA is expediting reviews for Merck's drugs, enlicitide decanoate and sacituzumab tirumotecan, potentially leading to significant sales. The initiative is part of the National Priority Voucher program, aiming to hasten drug approvals critical for public health. Merck's trial successes hint at groundbreaking market impacts.

The U.S. Food and Drug Administration is expediting the review process for two of Merck's potentially lucrative drugs, according to documents obtained by Reuters. These drugs, enlicitide decanoate for cholesterol and sacituzumab tirumotecan for cancer, are entering the Commissioner's National Priority Voucher program, which aims for faster FDA decisions by reducing review times to one or two months instead of the usual 10 to 12 months.

Reports suggest that Merck is planning to submit applications for enlicitide in April and for sacituzumab tirumotecan in late next year. The new voucher program, launched in June, is particularly targeting drugs with critical public health or national security benefits. The program will dramatically shorten the review timeline for crucial drugs, including one major weight-loss pill from Eli Lilly, with a total evaluation timeline of six months.

Despite the pending formal announcement, this step is part of broader efforts to enhance public health interventions while boosting the market potential of new medical treatments. Merck is notably working on steering market dynamics before its leading cancer treatment, Keytruda, faces competition from biosimilar alternatives. Meanwhile, a $700 million partnership with Blackstone Life Sciences for sacituzumab tirumotecan development, suggests the drug might achieve over $10 billion in annual sales.

(With inputs from agencies.)