Menarini Group's Obicetrapib and Obicetrapib/Ezetimibe Marketing Authorisation Applications Accepted for Review by the European Medicines Agency (EMA) for the Treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia

USA - English

• USA - español

• If approved, obicetrapib, licensed from NewAmsterdam Pharma, would be the first CETP inhibitor to be available, as an adjunct to diet, for patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or in patients who are statin-intolerant, or for whom a statin is contraindicated.
• Obicetrapib: The submission is supported by results from the pivotal Phase 3 studies BROOKLYN and BROADWAY, conducted by NewAmsterdam Pharma, showing a statistically significant difference in the efficacy in favor of obicetrapib on top of maximally tolerated lipid lowering therapies compared to placebo
• Obicetrapib/Ezetimibe:The submission is supported by results from the pivotal Phase 3 study TANDEM, conducted by NewAmsterdam Pharma, showing a statistically significant difference in the efficacy in favor of obicetrapib/ezetimibe on top of maximally tolerated lipid lowering therapies compared to each of placebo, ezetimibe 10 mg, and obicetrapib 10 mg monotherapy     

FLORENCE, Italy, Sept. 2, 2025 /PRNewswire/ -- Menarini Group (Menarini), an Italy-based, privately held, international pharmaceutical company today announced that EMA has validated the Marketing Authorization Application (MAA) for obicetrapib,  a selective cholesteryl ester transfer protein (CETP) inhibitor, and obicetrapib/ezetimibe fixed dose combination as an adjunct to diet for patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or who are statin-intolerant, or for whom a statin is contraindicated. The validation of both applications confirms that the submission is complete and begins the EMA's centralized review procedure.

"Cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives each year. Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen, and patients remain above LDL-C targets, failing to achieve guidelines recommended LDL-C target goals.  Patients and their doctors need additional options" said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. "Obicetrapib, if approved, could provide an effective and safe oral option for patients with hypercolesterolemia. We look forward to working with the Agency to potentially bring this new treatment to patients in need."

The Phase 3 BROOKLYN (NCT05425745), BROADWAY (NCT05142722) and TANDEM (NCT06005597) studies evaluated obicetrapib and obicetrapib/ezetimibe on top of maximally tolerated lipid lowering therapies compared to placebo in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or in patients who are statin-intolerant, or for whom a statin is contraindicated. BROADWAY and TANDEM were published on NEJM and The Lancet. The Phase 3 PREVAIL cardiovascular outcomes trial started in March 2022, and is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular (CV) events in patients with hypercholesterolemia at very high CV risk. Enrollment completion occurred in April 2024 and the study randomized over 9,500 patients.

The Menarini Group obtained rights for obicetrapib and obicetrapib /ezetimibe in Europe, UK and Switzerland in June 2022 from New Amsterdam Pharma who conducted and successfully completed the pivotal BROOKLIN, BROADWAY and TANDEM studies. Based on the positive phase 3 data, Menarini submitted two Marketing Authorization Applications to EMA, obicetrapib and obicetrapib/ezetimide.

About Obicetrapib
Obicetrapib is a next-generation oral, low-dose and once-daily CETP inhibitor in development for lowering low-density lipoprotein cholesterol (LDL-C) and preventing major adverse cardiovascular events. More than 100 million people globally are not achieving LDL-C goals despite the current available standard of care. In the pivotal Phase 3 BROOKLYN, BROADWAY¹ and TANDEM² trials, obicetrapib, as monotherapy or combination therapy with ezetimibe, was observed to statistically significantly lower LDL-C and had a good safety profile.

About Menarini
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4,5 billion and over 17,000 employees. Menarini is focused on Primary & Specialty Care, Oncology and Consumer Healthcare, covering therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit www.menarini.com.

About NewAmsterdam Pharma
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated, thus seeking to fill a significant unmet need for a safe, well tolerated and convenient LDL lowering therapy. For more information, please visit: www.newamsterdampharma.com.

1. S.J. Nicholls et al. Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk. NEJM May 7, 2025.
2. Ashish Sarraju et al. Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial. The Lancet May 7, 2025

Logo - https://mma.prnewswire.com/media/2296569/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg

SOURCE Menarini Industrie Farmaceutiche Riunite