AMLYPAVE (Anselamimab)

AMLYPAVE (anselamimab), from Alexion, AstraZeneca Rare Disease, was approved in Japan in September 2026 for systemic AL (light-chain) amyloidosis. The Japanese approval is restricted to patients whose abnormal immunoglobulin light chain is kappa-type dominant (confirmed, for example, by the kappa/lambda ratio) and who have Mayo stage IIIa or IIIb cardiac disease.

In AL amyloidosis, misfolded light chains build up as amyloid fibrils in the heart and other organs. Anselamimab is a monoclonal antibody designed to bind these deposited fibrils and help the body clear them. In the Phase III CARES programme the overall population did not reach statistical significance, but a prespecified subgroup showed a clinically meaningful improvement in time to all-cause death and cardiovascular hospitalisation, which forms the basis of the restricted Japanese indication.

• Use is limited to kappa-type dominant AL amyloidosis at Mayo stage IIIa or IIIb; light-chain typing must be confirmed before treatment.
• AMLYPAVE is approved in Japan only; the Japanese package insert should be reviewed for full dosing, safety and monitoring requirements.
• Treatment should be managed by a haematologist or cardiologist experienced in amyloidosis, alongside standard plasma-cell-directed therapy.

What documents are required to import AMLYPAVE to India?

AMLYPAVE 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 haematologist or cardiologist
• Biopsy and laboratory report confirming systemic AL amyloidosis, kappa-type dominance and Mayo stage
• 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.

Is AMLYPAVE available in India?

AMLYPAVE was approved in Japan in September 2026 (its first approval) and is not available in India. It can be legally accessed through the Named Patient Program (NPP), subject to applicable regulations.

Indian Pharma Network (IPN) can source AMLYPAVE from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

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

Global Approval Status:

• Japan: Approved — 16 September 2026 (kappa-type AL amyloidosis, Mayo stage IIIa/IIIb).
• United States / European Union: Not approved as of October 2026.

What is AMLYPAVE used for?

AMLYPAVE (anselamimab) is a first-in-class anti-light-chain amyloid fibril monoclonal antibody used for advanced kappa-type systemic AL amyloidosis.

Who manufactures AMLYPAVE?

AMLYPAVE is from AstraZeneca (Alexion).

How does AMLYPAVE work?

Anselamimab is a monoclonal antibody designed to bind light-chain amyloid fibrils deposited in organs such as the heart and help the body clear them.

Does AMLYPAVE replace chemotherapy for AL amyloidosis?

No. It targets amyloid deposits already in the organs and is used alongside treatments that suppress the abnormal plasma cells.

Is AMLYPAVE approved by the US FDA?

No. As of October 2026 it is approved only in Japan.