Enlicitide chloride

Bengaluru: 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)

Washington : US president Donald Trump on Friday secured new agreements with nine major pharmaceutical companies that said they will lower the cost of prescription drugs for Medicaid recipients and people who pay out of pocket, marking another step in his push to narrow the gap between US drug prices and those in other wealthy countries, as per a report. Trump Announcement Today Targets High Drug Costs in the US The deals include some of the largest names in the pharmaceutical industry, such as Bristol Myers Squibb, Gilead Sciences, Merck, and Roche’s US unit Genentech. Novartis, Amgen, Boehringer Ingelheim, Sanofi, and GSK have also agreed to participate, as per a Reuters report. Under the agreements, each company will reduce prices on most of the drugs it sells through Medicaid, the government health program for low-income Americans. Officials described the expected impact as “massive savings” on commonly used medicines, though they did not release specific numbers. This move comes as US consumers currently pay far more for prescription drugs than patients in other developed nations, often close to three times as much, an issue Trump has repeatedly highlighted. TrumpRx Program Could Lower Cash-Pay Drug Costs Nationwide Beyond Medicaid, the deals also cover lower cash-pay prices for select medicines sold directly to consumers, potentially through the TrumpRx.gov website. Drugmakers also agreed that new drugs introduced in the US will be priced no higher than those in other wealthy countries. In exchange, participating companies can receive a three-year exemption from tariffs and commit to expanding manufacturing. Merck to Offer Discounts on Diabetes Drugs Under TrumpRx Merck detailed its plans, saying it will sell its diabetes treatments Januvia, Janumet, and Janumet XR directly to US consumers at about 70% off list prices, as per the Reuters report. Those drugs are expected to face generic competition next year. If approved, Merck’s experimental cholesterol drug enlicitide will also be offered through direct-to-consumer channels. Enlicitide is expected to undergo a fast-track review by the FDA. Major Drugmakers Sign On to Trump Rx Pricing Plan The agreements follow pressure Trump applied earlier this year, when he sent letters to 17 major drugmakers urging them to adopt “most-favored-nation” pricing for Medicaid and to ensure new drugs are not launched in the US at higher prices than abroad. Five companies, Pfizer, Eli Lilly, AstraZeneca, Novo Nordisk, and EMD Serono, had already reached similar deals with the administration. Three major companies, Regeneron, Johnson & Johnson, and AbbVie, have yet to announce agreements. However, AbbVie is reportedly expected to finalize a deal on Friday, as per Reuters. Most-Favored-Nation Pricing Central to Trump Drug Prices Strategy Meanwhile, as part of the broader commitments, the drugmakers agreed to apply most-favored-nation pricing to all new US drug launches across commercial, government, and cash-pay markets, including Medicare. Officials also said a portion of revenue from foreign sales will be returned to the US to help offset costs, reported Reuters. What Comes Next After Trump’s Drug Price Announcement The companies collectively pledged more than $150 billion in US investment for research, development, and manufacturing, though it was unclear whether that figure includes earlier commitments. Merck said it alone would contribute $70 billion, as per the Reuters report. Several firms also agreed to donate drug ingredients to the US strategic reserve. Analysts noted that Medicaid already benefits from substantial discounts, sometimes exceeding 80 per cent, and Pfizer has warned that the expanded Medicaid discounts could compress prices and margins in 2026. FAQs Which companies are part of the Trump drug prices deal? Companies include Merck, Bristol Myers Squibb, Gilead Sciences, Genentech, Novartis, Amgen, Sanofi, GSK, and Boehringer Ingelheim. How will TrumpRx affect Medicaid patients? Most drugs sold through Medicaid will see price cuts, which officials say could lead to massive savings. By Shreya Biswas ,