Organon, a global healthcare company focused on delivering impactful medicines and solutions for everyday health, has entered into an agreement with Daiichi Sankyo Europe to commercialize Nilemdo (bempedoic acid) across France, Denmark, Iceland, Sweden, Finland, and Norway.

The agreement strengthens Organon’s cardiovascular disease portfolio and leverages its commercial expertise to expand access to innovative lipid-lowering therapies for patients with dyslipidemia, particularly those who are statin-intolerant.

The collaboration aims to address a significant unmet need in cardiovascular care that disproportionately affects women, who face a 47 per cent higher risk of statin intolerance compared with men.

Nilemdo is a first-in-class lipid-lowering therapy indicated for patients with elevated cholesterol levels and increased cardiovascular risk. It offers an alternative treatment option for patients who are unable to achieve adequate cholesterol reduction with statins or who cannot tolerate statin therapy.

“This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s cardiovascular innovation to bring Nilemdo to patients across Northern Europe and France,” said Thibault Crosnier Leconte, Associate Vice President and Managing Director, Organon Northwest Europe. “By providing a new treatment option for patients who cannot tolerate statins, we are helping to close a persistent gap in cardiovascular care—one that disproportionately affects women—while advancing our mission to deliver impactful treatments for a healthier every day.”

Cardiovascular disease remains the leading cause of death in Europe and among women globally. Despite its prevalence, it continues to be under-recognized, under-diagnosed, and under-treated, particularly in female populations.

Nilemdo is currently the only therapy in its class available in these markets, offering healthcare professionals a new option to reduce cardiovascular risk in patients who cannot reach target low-density lipoprotein cholesterol (LDL-C) levels with statins or other lipid-lowering therapies, or for whom statins are contraindicated.

Under the terms of the agreement, Organon will be responsible for the distribution and promotion of Nilemdo in the covered territories. Daiichi Sankyo Europe will retain marketing authorization for the product, while Organon will act as the local representative.

Nilemdo contains bempedoic acid, which works by inhibiting ATP-citrate lyase, a key enzyme involved in cholesterol biosynthesis. The drug received European Medicines Agency approval in February 2020.

It is indicated for adults with primary hypercholesterolaemia or mixed dyslipidaemia, either in combination with statins or other lipid-lowering therapies, or as monotherapy or combination therapy for patients who are statin-intolerant or unable to use statins. Nilemdo is also indicated for adults with established or high risk of atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels.

The recommended dose is 180 mg taken orally once daily, with or without food. Patients receiving Nilemdo should be monitored regularly to assess treatment effectiveness and safety.

Organon has a portfolio of more than 70 products spanning women’s health and general medicines, including biosimilars. The company focuses on addressing health conditions that uniquely, disproportionately, or differently affect women, while expanding access to essential therapies in over 140 markets worldwide. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare.