European Commission

SpringWorks Therapeutics’ EZMEKLY® (mirdametinib) received conditional EU approval for NF1-PN in adults and children (2+), marking the first and only EU-approved therapy for this rare genetic disorder. Backed by Phase 2b ReNeu trial data (n=114), EZMEKLY showed objective response rates of 41% in adults and 52% in pediatric patients, with ~41-42% median tumor volume reduction and durable responses. Available in capsule and dispersible tablet forms, EZMEKLY addresses a significant unmet need in an estimated 135,000 EU patients.

Halozyme Therapeutics announced the European Commission’s approval of argenx’s VYVGART subcutaneous injection, utilizing Halozyme’s ENHANZE drug delivery technology, for chronic inflammatory demyelinating polyneuropathy (CIDP). This approval, based on positive ADHERE trial data, marks a significant advancement for CIDP treatment and expands drug access across Europe. VYVGART, the first targeted IgG Fc-antibody fragment for CIDP, represents a new treatment mechanism in over three decades. The SC injection can be administered by patients, caregivers, or healthcare professionals.