Fierce Pharma

Novartis scores FDA approval for new version of SMA gene therapy, prices at $2.59M

Novartis is pricing Itvisma at a wholesale acquisition cost of $2.59 million, a company spokesperson told Fierce Pharma. At ...
BioSpace

Novartis Expands Spinal Muscular Atrophy Gene Therapy Market With FDA’s Itvisma Greenlight

The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access ...
Pharmaceutical Technology on MSN

Novartis secures approval from FDA for Itvisma to treat SMA

The approval is supported by findings from the open-label Phase IIIb STRENGTH study and the Phase III STEER study.

Novartis receives FDA approval for Itvisma(R), the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA)

ITVISMA is a prescription gene therapy used to treat adults and children 2 years of age and older with spinal muscular atrophy (SMA). ITVISMA is given as a one-time intrathecal injection. What is the ...

FDA approves Novartis’ Itvisma, first gene therapy for SMA patients 2 and older

Novartis (NVS) on Monday said that the U.S. FDA has approved Itvisma for the treatment of children two years and older, teens ...
MedPage Today on MSN

FDA Gives Broad Approval to Gene Therapy for Rare Neurologic Disease

The FDA approved the intrathecal gene therapy onasemnogene abeparvovec (Itvisma) to treat spinal muscular atrophy (SMA) in ...
New Jersey Business Magazine

Novartis Receives FDA Approval for Spinal Muscular Atrophy Gene Replacement Therapy

The FDA has approved Itvisma for the treatment of children two years and older, teens and adults living with spinal muscular ...
pharmaphorum

Novartis' SMA gene therapy cleared for wider use in US

The new intrathecal formulation means the one-shot gene therapy is now available to all SMA patients, regardless of their age ...
Applied Clinical Trials Online

FDA Clears Itvisma as First Gene Therapy for Adolescents and Adults With SMA

The FDA has approved Novartis’ Itvisma (onasemnogene abeparvovec-brve) for the treatment of adolescents two years and older, teens, and adults living with spinal muscular atrophy (SMA) with a ...