Nipocalimab's approval: When is the latest treatment for myasthenia gravis coming to you?

Myasthenia gravis is a rare autoimmune condition, which affects mostly people over the age of 50. In the past 5 years, multiple treatments have been approved for this condition. Including Zilbrysq, Rystiggo, Ultomiris, and Vyvgart. Despite these advances, these therapies benefit only 60-70% of patients. According to Dr Richard Nowak, a significant portion of patients are left without substantial improvement ¹.

Nipocalimab is a new investigational medicine that shows potential to change this situation. Early clinical data suggest it may address more myasthenia gravis patients than current treatments.

So, when will nipocalimab be available? Here's what you need to know about the projected timelines for FDA, EMA, MHRA approvals, and more.

What is nipocalimab, the latest treatment for myasthenia gravis?

Nipocalimab is a monoclonal antibody in development. It's designed to work by targeting the neonatal Fc receptor (FcRn). FcRn regulates harmful IgG antibodies involved in myasthenia gravis (and other autoimmune conditions). By blocking FcRn, nipocalimab aims to reduce the levels of harmful antibodies that attack the body's own tissues. This way, it aims to ease symptoms without weakening the entire immune system ².

Apart from myasthenia gravis, nipocalimab is being studied as a potential treatment for other conditions. Including chronic inflammatory demyelinating polyneuropathy and warm autoimmune hemolytic anemia. It’s also being researched for maternal-fetal diseases like hemolytic disease of the fetus and newborn (HDFN). Last but not least, nipocalimab is also in clinical trials related to more common autoimmune disorders such as rheumatoid arthritis, Sjögren’s disease, and lupus ³.

What is nipocalimab's success rate in clinical trials?

In the Phase 3 VIVACITY clinical trial, nipocalimab was used along with standard treatment against placebo and standard treatment. The patient population involved in the trial accounted for about 95% of the myasthenia gravis patient population.

Here's what the key reported outcomes of the trial were:

• Patients treated with nipocalimab showed a 4.7-point improvement on a symptom scale (MG-ADL). In comparison, the placebo group showed a 3.25-point improvement. For context, a 1-2 point improvement on this scale can make a big difference in everyday activities, such as eating without choking or breathing without assistance;

• Nipocalimab significantly improved muscle strength and function (measured by QMG) compared to placebo;

• More patients on nipocalimab experienced a 2-point or greater improvement on the MG-ADL scale. This shows its potential to improve daily life for people with gMG ⁴.

The results of the VIVACITY trial led Johnson & Johnson to apply for FDA approval of nipocalimab in August 2024.

Nipocalimab vs efgartigimod: What's the difference?

Efgartigimod (branded as Vyvgard) was approved in 2021 for the treatment of myasthenia gravis.

Efgartigimod is similar to nipocalimab in that it also aims to block the FcRn protein. However, there are some differences between the two medicines, including:

• Applicability. Based on the currently available data, nipocalimab appears to be applicable to a larger patient population. Including patients with anti-MuSK, anti-LRP4, and anti-AChR antibodies. Nipocalimab could potentially also serve as a second-line option for patients who haven't responded well to efgartigimod ⁵.

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  Approval status. While Vyvgard (efgartigimod) is already approved in the USA and the EU, nipocalimab is yet to get its first global approval.

Nipocalimab's approval status around the world

While the initial clinical trial data are promising, nipocalimab is not yet approved anywhere in the world. Here's what we know about its global approval timelines.

When is FDA approval expected?

Nipocalimab's FDA approval application was filed in August 2024. Typically, an approval decision takes from 6 to 10 months, meaning that nipocalimab should be getting the FDA's green light by mid-2025.

When will nipocalimab get EMA approval?

Johnson & Johnson submitted their EMA marketing authorization application for nipocalimab in September 2024. EMA approval decisions can take up to 210 days, which takes us to the middle of 2025, when hopefully nipocalimab will get its approval in the EU.

When is nipocalimab going to be available in the UK?

This is a harder question to answer, as there is no active MHRA approval application for nipocalimab as of September 2024. According to post-Brexit regulations, the MHRA can choose to approve nipocalimab as soon as another trusted body approves it (e.g. the FDA or EMA). If that's the direction the MHRA chooses, then nipocalimab could be approved in the UK around mid-2025 as well. Before it can be available on the NHS, it would have to be assessed by NICE. An assessment is already underway, without a publication date available as of this moment.

How to get nipocalimab before it's approved in your country

Are you a myasthenia gravis patient? If your doctor is of the opinion that you might benefit from treatment with nipocalimab, you may not need to wait for its local approval. Instead, your doctor and you could consider joining a clinical trial. Or, buying nipocalimab via Named Patient Import, as soon as it gets approval somewhere in the world.

Join a clinical trial

One way to access medicines in development is to enroll in a clinical trial. This can often be easier said than done, as you and your doctor would need to find a trial that is currently recruiting participants in your country. You would also have to meet their eligibility criteria and accept the risk that you may be assigned to the control group in the trial.

Here are some good places to start looking for ongoing nipocalimab clinical trials:

• ClinicalTrials.gov: This is a database with all clinical trials in the USA. Some of the trials are also open to international participants, so it's a list worth keeping an eye on.

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  EUClinicaltrials.eu: This is a database with all clinical trials in the European Union. Currently, it contains limited information on trials launched before 31 January 2022. For those trials, you can refer to the EU Clinical Trials Register.

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  myTomorrows: This organization supports patients in finding treatment options in clinical trials.

Buy nipocalimab via Named Patient Import

In most countries, patients can buy and import medicines that could enhance their quality of life or address life-threatening conditions. If you want to access nipocalimab before its approval in your country, this might be an option for you and your doctor. You could make use of it as soon as the medicine gets an approval somewhere in the world.

The regulation making this possible is known as the Named Patient Import. There may be variations across countries in terms of the specific administrative requirements. However, in all cases these criteria must be met:

• The medicine in question has market approval in another country and is not (yet) approved or available in the patient's country;
• There is no alternative on the local market;
• The medicine is for personal use;
• The patient has a prescription from their treating doctor;
• The doctor takes responsibility for the treatment. This might require different documentation from country to country.

Do you want to use the Individual Named Patient Import regulation to get nipocalimab before its local approval? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Our team can support you with buying nipocalimab, as soon as it's approved somewhere in the world. Get in touch with us for more information.

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References:

1. KATELLA, KATHY. Myasthenia Gravis: New Drugs and a Road to Individualized Treatment. Yale Medicine, 17 November 2023.
2. What is Nipocalimab used for?, Synapse, 28 June 2024. 
3. Johnson & Johnson's nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN). Johnson & Johnson, 9 February 2024.
4. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients. PR Newswire, 28 June 2024.
5. J&J readies nipocalimab to compete with Vyvgart after myasthenia gravis trial success. Synapse, 15 July 2024.