#Italy #Florence #Obicetrapib #Ubeslo #Evlarco

European Commission Approval for Ubeslo® and Evlarco®

On September 21, 2026, Menarini Group and NewAmsterdam Pharma jointly announced that the European Commission has granted approval for two new medications: Ubeslo® (Obicetrapib as monotherapy) and Evlarco® (a fixed-dose combination of Obicetrapib and Ezetimibe). This significant milestone represents the world's first regulatory approval for Obicetrapib, marking a hopeful advancement in the treatment of patients suffering from primary hypercholesterolemia.

A Breakthrough in Treatment Options

The approval signals a new horizon for patients struggling to manage their low-density lipoprotein cholesterol (LDL-C) levels, especially those unable to achieve adequate results with current treatment options. Dr. Michael Davidson, CEO of NewAmsterdam Pharma, emphasized the importance of this approval as a validation of years of research aimed at providing new solutions for patients who continue to face challenges in reaching recommended LDL-C levels.

The European Commission’s decision was founded on evidence from extensive Phase 3 clinical studies: BROADWAY, BROOKLYN, and TANDEM, revealing significant reductions in LDL-C levels—up to 40% with Obicetrapib monotherapy compared to placebo, and around 50% when combined with Ezetimibe. Importantly, these results were obtained with a safety profile similar to that of placebo, underscoring Obicetrapib's potential for broader use.

Collaboration Between Menarini and NewAmsterdam

As part of the licensing agreement, Menarini has secured exclusive marketing rights for Obicetrapib in Europe, handling regulatory collaborations and marketing initiatives across the region. Both companies plan to capitalize on this approval to increase access to Ubeslo and Evlarco for European patients as well as to pursue ongoing clinical development in multiple Phase 3 studies, including PREVAIL, REMBRANDT, and RUBENS.

Elcin Barker Ergun, CEO of Menarini, remarked, “This approval represents a critical advancement for patients throughout Europe who require additional tools to lower their LDL-C levels despite available therapies.” Menarini aims to leverage its extensive experience in the cardiovascular sector to ensure that Ubeslo and Evlarco reach those most in need.

Obicetrapib’s Clinical Promise

Obicetrapib is a novel CETP inhibitor being developed as a promising oral therapy intended to overcome the limits of current LDL-lowering treatments. In prior clinical trials, it demonstrated a statistically significant reduction in LDL levels with a side effect profile comparable to placebo. The clinical program aims to address a significant unmet medical need given the alarming rise of cardiovascular disease impacting millions globally.

Heart diseases remain the leading cause of death worldwide, with a substantial number of individuals unable to achieve target LDL-C levels despite treatment. A staggering prediction suggests that by 2050, over 184 million adults in the United States will be affected by cardiovascular diseases and hypertension. With many patients falling short of LDL-C goals, innovative treatments like Ubeslo and Evlarco may provide critical support.

Future Directions

Following the approval, NewAmsterdam looks forward to further developing Obicetrapib and exploring additional treatment modalities to meet the diverse needs of patients. The company’s vision is focused on improving patient outcomes while addressing broader cardiovascular risks that are often associated with lifestyle and health conditions.

In conclusion, the approval of Ubeslo and Evlarco signifies a promising step forward in the realm of cardiovascular health, offering hope to those struggling with hypercholesterolemia. As both companies accelerate their efforts to implement these therapies in clinical practice, the health landscape for patients may evolve significantly.