NewAmsterdam Pharma Company N.V. announces the acceptance of Marketing Authorization Applications by the European Medicines Agency (EMA) for Obicetrapib.
Obicetrapib monotherapy and Obicetrapib plus ezetimibe fixed-dose combination are submitted for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia.
The MAAs were submitted by NewAmsterdam's partner, Menarini, for review of pivotal Phase 3 trials.
Key Takeaways
Royalties and Milestones
NewAmsterdam entitled to tiered double-digit percentage royalties on net sales in the Menarini Territory and up to €833 million upon milestone achievements.
Clinical Trials Data
Phase 3 trials showed significant LDL-C reductions with Obicetrapib monotherapy and in combination with ezetimibe.
Partnership with Menarini
Menarini responsible for the commercialization and local development of Obicetrapib in Europe under an exclusive License Agreement.
Impact Analysis
- The acceptance of MAAs by the EMA marks a significant step towards bringing a novel therapeutic option to patients at risk of cardiovascular disease.
- Obicetrapib's potential approval could offer additional options for patients failing to achieve recommended LDL-C target goals.
Conclusion
The acceptance of MAAs by the EMA paves the way for further development and potential approval of Obicetrapib for treating hypercholesterolemia, addressing the unmet needs of patients at risk of cardiovascular disease.