Novartis announces CHMP of EMA adopted positive opinion for Itvisma

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion recommending marketing authorization for Itvisma. The opinion supports its use for the treatment of children two years and older, teens, and adults living with 5q spinal muscular atrophy with a bi-allelic mutation in the survival motor neuron 1 gene. The CHMP opinion is based on data from the registrational Steer study, and supportive Phase IIIb Strength and Phase I/II Strong studies. In Steer, Itvisma demonstrated a statistically significant 2.39-point improvement in the Hammersmith Functional Motor Scale with effects sustained over 52 weeks of follow-up. The Steer and Strength studies also showed clinically meaningful benefit for treatment-naive and pre-treated patients.