Merck KGaA’s Strategic SpringWorks Acquisition Yields Key European Approvals
14.09.2025 - 11:27:05European Regulatory Milestones Achieved
Merck KGaA’s recent $3.9 billion acquisition of SpringWorks Therapeutics is demonstrating immediate strategic value, with European regulators granting marketing authorization for two key therapies that significantly bolster the company’s presence in the rare disease market.
The European Commission granted approval on August 18, 2025, for OGSIVEO® (nirogacestat) as a treatment for adults with progressing desmoid tumors. This decision followed the conditional marketing authorization awarded on July 18, 2025, for EZMEKLY® (mirdametinib) targeting neurofibromatosis type 1-associated plexiform neurofibromas in patients aged two years and older.
These regulatory successes stem from positive assessments issued by the European Medicines Agency’s CHMP committee in May and June of 2025. Both therapeutic options had previously received approval from the U.S. Food and Drug Administration.
