CHMP greenlights Novartis’ Zolgensma

The CHMP recommened two drugs from Novartis AG. Firstly, the Swiss pharma giant’s US subsidiary AveXis  received conditional EU approval of its spinal muscular atrophy gene therapy Zolgensma in infants with functional mutations in the SMN1 gene or with SMN2 trisomy. Secondly, the EMA backed Novartis’ asthma sprays Atectura Breezhaler (indacaterol/mometasone furoate) and Bemrist Breezhaler (indacaterol /mometasone furoate).

Furthermore, the Committee recommended granting a marketing authorisation for Seqirus Netherlands BV’s preventive influenza vaccine Fluad Tetra and FGK’s Pretomanid FGK (pretomanid) for the treatment of tuberculosis in combination with bedaquiline and linezolid.

Futhermore, the CHMP recommended market approval of Sanofi’s Sarclisa (isatuximab) for the treatment of multiple myeloma. Zeposia (ozanimod), which was developed by Celgene Europe BV, received a positive opinion for the treatment of adult patients with relapsing remitting multiple sclerosis.

Mylan IRE Healthcare’s biosimilar medicine Nepexto (biosimilar etanercept) received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.