ITVISMA (Onasemnogene Abeparvovec-brve)

ITVISMA (onasemnogene abeparvovec-brve), from Novartis, is a one-time, intrathecal gene replacement therapy indicated for patients 2 years of age and older with spinal muscular atrophy (SMA) who have a confirmed biallelic SMN1 mutation. It is the first gene replacement therapy approved for this broader (older child, teen, and adult) SMA population, delivered via intrathecal (spinal) administration rather than IV infusion.

ITVISMA works by delivering a functional copy of the SMN1 gene directly into the central nervous system, aiming to replace the missing or nonfunctional gene responsible for SMA and support motor neuron survival and function.

• Acute serious liver injury has been reported with AAV-based gene therapies in this class; liver function must be monitored before and after dosing, with corticosteroid prophylaxis as directed.
• Thrombotic microangiopathy (TMA) has been reported; platelet counts and other markers should be monitored.
• As an intrathecal procedure, standard risks of lumbar puncture/spinal administration apply.
• Common side effects: elevated liver enzymes, vomiting, fever, headache.

What documents are required to import ITVISMA to India?

ITVISMA may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered neurologist
• Genetic test report confirming biallelic SMN1 mutation (SMA diagnosis)
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription and an import permit, if applicable.

Is ITVISMA available in India?

ITVISMA is not commercially marketed in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source ITVISMA from Novartis’ authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. As a specialized one-time gene therapy, sourcing and logistics are coordinated closely with the treating center.

For ITVISMA cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — November 24, 2025.

What is ITVISMA used for?

ITVISMA is a one-time gene replacement therapy for spinal muscular atrophy (SMA) in patients 2 years and older with a confirmed biallelic SMN1 mutation.

Who manufactures ITVISMA?

ITVISMA is manufactured by Novartis.

How is ITVISMA different from Zolgensma?

ITVISMA is an intrathecal (spinal) formulation of the same onasemnogene abeparvovec gene therapy as Zolgensma, enabling administration in older children, teens, and adults rather than only infants.

How much does ITVISMA cost in India?

As a specialized one-time gene therapy, cost depends on sourcing logistics and case-specific factors — share your prescription and genetic test report with IPN for a quote.