KLYGEFA (Gefurulimab)

KLYGEFA (gefurulimab), from Alexion, AstraZeneca Rare Disease, is approved in Japan and recommended for approval in the EU as an add-on to standard therapy for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Gefurulimab binds the complement protein C5 and stops it from being split into C5a and C5b, switching off the terminal complement attack on the neuromuscular junction. It also binds albumin in the blood, which extends its half-life and allows once-weekly self-injection. In the Phase III PREVAIL trial, it reduced disease severity and improved daily function (MG-ADL, QMG) and quality of life compared with placebo.

• The most common side effects reported to the EMA were injection site reactions, back pain, joint pain, muscle spasms, muscle pain, and nausea and vomiting.
• As a complement inhibitor, it should be used under a neurologist experienced in myasthenia gravis, following all infection-related precautions in the approved product information.
• EU marketing authorisation is pending the European Commission decision; the full EU product information will be published after authorisation.

Is KLYGEFA available yet?

KLYGEFA is approved in Japan (16 September 2026) and some other countries. In the EU it has a positive CHMP opinion and awaits the European Commission decision, and it is under review in the US and China. We can check current supply options for your neurologist.

How is KLYGEFA given?

Treatment starts with a single loading dose based on body weight on day 1, followed by once-weekly maintenance doses from day 8, injected under the skin with an autoinjector.

What documents do we need?

• A prescription from a neurologist stating the dose
• A report confirming generalised myasthenia gravis with positive anti-AChR antibodies
• Photo ID of the patient, or hospital details if the order comes from the hospital

We go through the neurologist’s prescription and antibody report before confirming anything.

Are there special precautions before starting?

As with other complement C5 inhibitors, the treating neurologist will follow the infection-prevention steps in the approved product information before starting treatment.

KLYGEFA was approved only recently, and supply routes outside Japan are still being set up. We keep track of its approvals and check availability with authorised channels before confirming an order.

For KLYGEFA availability and price, call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557, or email info@indianpharmanetwork.in.

Global Approval Status:

• Japan: Approved on 16 September 2026.
• European Union: Positive CHMP opinion on 17 September 2026; the European Commission decision is still pending.
• United States: Under regulatory review.

Sources:

• AstraZeneca: KLYGEFA recommended for approval in the EU (September 2026)
• EMA – CHMP meeting highlights, 14–17 September 2026

Information last checked: November 2026.

What is KLYGEFA indicated for?

It is a weekly self-injected complement C5 inhibitor, prescribed for AChR antibody-positive generalised myasthenia gravis in adults.

Which company makes KLYGEFA?

AstraZeneca (Alexion).

What is the mechanism of KLYGEFA?

Gefurulimab binds the complement protein C5 and stops it from being split into C5a and C5b, switching off the terminal complement attack on the neuromuscular junction.

Can KLYGEFA be given at home?

AstraZeneca describes it as a once-weekly subcutaneous injection that patients can give themselves with an autoinjector, after a weight-based loading dose on day 1.

How quickly does KLYGEFA work?

In the PREVAIL trial, AstraZeneca reports that improvement in daily activities was seen as early as week one and was sustained through week 26.

Does KLYGEFA have FDA approval?

Not yet. Applications are under review in the US and China.