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 ...
Managed Healthcare Executive

FDA approves $2.59 million gene therapy for SMA

The FDA has approved Itvisma (onasemnogene abeparvovec-brve) to treat children two years and older, teens, and adults living with spinal muscular atrophy (SMA). It is indicated for patients with a ...

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 ...
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 ...
Monthly Prescribing Reference

Apitegromab Gets Priority Review for Spinal Muscular Atrophy

A Prescription Drug User Fee Act target date of September 22, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License ...

US FDA approves Novartis' gene therapy for rare muscle disorder

The therapy, branded as Itvisma, was approved for the treatment of spinal muscular atrophy patients of age two years and ...
Monthly Prescribing Reference

Long-Term Data Demonstrate Sustained Efficacy of Risdiplam in Spinal Muscular Atrophy

In Part 2 of the trial, patients 2-25 years of age received either risdiplam for 24 months or placebo for 12 months followed by risdiplam for 12 months. Treatment with risdiplam was associated with ...
Healio

Gene therapy slows progression of spinal muscular atrophy type 2

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Back to Healio Topline results from a phase 3 clinical ...
MedPage Today

Motor Function in Spinal Muscular Atrophy May Improve With Adjunctive Apitegromab

Some patients with later-onset spinal muscular atrophy (SMA) type 2 and type 3 had improved motor function when the investigational monoclonal antibody apitegromab was added to their treatment, the ...