When will momelotinib be approved in Europe and the UK?

Ojjaara (momelotinib) is the first medicine to receive FDA approval for treating myelofibrosis (MF) patients with anaemia [1]. Anaemia affects about 38% of newly-diagnosed MF patients. And even more as the disease progresses. It has been shown to decrease quality of life and is associated with a more negative disease prognosis ².

Momelotinib's approval is an important milestone in bone marrow cancer treatment.

Despite getting a green light from the FDA, the EMA's approval for Momelotinib is still pending. If you're an MF patient in Europe or the UK, you're probably wondering when momelotinib will be approved. Here's everything you need to know. Including all your options for quickly and safely accessing Ojjaara before its EMA approval.

What is momelotinib used for?

Ojjaara (momelotinib) is a prescription medicine designed for adults with myelofibrosis. Especially those at intermediate or high risk. It's used to treat both the primary form of MF and forms that develop after other conditions. For example, polycythemia vera or essential thrombocythemia. Momelotinib is specifically intended for MF patients who also have anaemia.

Momelotinib works by blocking enzymes known as Janus Kinase 1 and 2 (JAK1/JAK2) and a mutant form of JAK2. All of these are crucial for controlling blood cell production and immune responses. Additionally, momelotinib targets the activin A receptor type 1 (ACVR1), influencing the body's iron regulation and red blood cell production.

In myelofibrosis, these enzymes are abnormally activated. This causes inflammation and irregular blood cell production. Momelotinib helps by inhibiting these signals, thereby reducing inflammation and improving blood cell production ¹.

Momelotinib EMA approval: What's the status?

In November 2023, the CHMP in Europe recommended granting marketing authorization to momelotinib (marketed as Omjjaara in Europe) ³.

A positive recommendation is not an official approval yet. It typically takes about two months for the CHMP's recommendation to be adopted and for a medicine to receive full EMA approval ⁴.

When will momelotinib be available in Europe?

Unfortunately, an EMA approval for momelotinib won't mean that it will be available right away in Europe. Before it reaches the pharmacies, the medicine's manufacturer and each member state's local health authority must make decisions about local approval, prices, and health insurance coverage. As a result, Omjjaara (momelotinib) will likely be available at different times in each country within Europe.

New medicines take on average 511 days after EMA approval to become available in Europe. This timeline is dramatically different per country. For orphan medicines such as momelotinib, it ranges from 102 days in Germany to 1,081 days in Estonia ⁵.

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When will momelotinib be available in the UK?

After Brexit, momelotinib's UK approval is no longer bound to the timelines of momelotinib's EMA approval. However, this doesn't always mean approvals can come quickly.

As of November 2023, Ojjaara (momelotinib) has not yet been approved by the MHRA in the UK. A review of the medicine by NICE is in progress, however. The NICE's review is essential to determine whether momelotinib will be available on the NHS. A decision is expected in March 2024 ⁶.

If the NICE's recommendation is positive, momelotinib should be available on the NHS within 3 months on average ⁷. That's assuming that the MHRA's approval is a fact in the meantime. Meaning that momelotinib should be available to MF patients in the UK around mid-2024.

Momelotinib approval status in the rest of the world

Momelotinib's application for approval is under review by the PMDA in Japan. However, no timeline for a decision is provided ⁸.

Ways to safely access Omjjaara (momelotinib) before its EMA approval

Are you an MF patient outside of the USA? You might not have to wait for momelotinib's EMA approval or MHRA approval. Instead, your doctor and you could explore clinical trials including momelotinib. Or, you can buy momelotinib right away as an Individual Named Patient.

Join a momelotinib clinical trial

You can join a clinical trial to get Omjjaara (momelotinib) or other unapproved medicines. Finding a trial recruiting participants in your country can be difficult, but it is possible. In order to participate in the trial, you must meet the eligibility criteria. You will also need your treating doctor's support.

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

• ClinicalTrials.gov: This is a database with all clinical trials in the USA. However, some of the trials are also open to international participants.
• EUClinicaltrials.eu: This database contains 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.
• myTomorrows: This organization supports patients in finding treatment options in clinical trials.

Buy momelotinib as an Individual Named Patient

In most countries, patients are legally allowed to buy and import medicines that could improve their lives or address life-threatening conditions. If you want to access momelotinib before its EMA approval or MHRA approval, this might be an option for you and your doctor.

The regulation that makes this possible is known as the Individual Named Patient Import regulation. Under the Individual Named Patient Import regulation, patients can import a medication not yet approved or available in their country if:

• it is approved elsewhere;
  
• has no local alternatives, and
  
• is for personal use.
  

This process requires a prescription from the treating doctor. They assume responsibility for the treatment. Per country, specific documentation requirements can vary.

Do you want to use the Individual Named Patient Import regulation to get momelotinib before its EMA or UK 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 momelotinib immediately.

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References:

1. GSK's Ojjaara receives FDA approval for treating myelofibrosis patients with anaemia, Pharmaceutical Technology, 21 September 2023.
2. Emerging Treatment Options, Myelofibrosis: Focus on Anemia | TCRM. Dove Medical Press, 28 June 2023.
3. Omjjara: Pending EC decision | European Medicines Agency. European Medicines Agency, 10 November 2023.
4. Applying for EU marketing authorisation for medicinal products for human use. European Medicines Agency, Accessed 20 November 2023.
5. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 20 November 2023.
6. Project information | Momelotinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis [ID6141] | Guidance. NICE, Accessed 20 November 2023.
7. Ewbank, Leo. Access to new medicines in the English NHS. The King's Fund, 28 October 2020.
8. Momelotinib Japan Filing Press Release. GSK, 11 September 2023.