CHMP Archives | Be Korea-savvy

CHMP Adopts Positive Opinion Recommending Approval of New and Expanded Indications for SPEVIGO®

The CHMP positive opinion is based on the EFFISAYIL® 2 trial, which showed that no flares were observed after week 4 of SPEVIGO® administered subcutaneously. During the 48-week trial, an 84% reduction of the risk of GPP flares was observed. GPP is a rare, chronic, heterogenous neutrophilic inflammatory disease associated with skin flares and systemic [...]

Lupin Neurosciences Announces Positive CHMP Opinion for NaMuscla™ for the Treatment of Myotonia in Non-Dystrophic Myotonic Disorders

ZUG, Switzerland, Oct. 19 (Korea Bizwire) - Lupin Neurosciences, a specialty pharma division of Lupin Ltd, today announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMuscla™ (mexiletine hydrochloride) for the symptomatic treatment of myotonia [...]