Ryzneuta's EMA approval: When is it coming (and how to avoid waiting)

One of the most common side effects of chemotherapy is neutropenia. It's a condition in which there are not enough white blood cells in the patient's blood stream. Neutropenia often becomes a reason to delay cancer treatment or lower chemotherapy dosage, thus potentially impacting a patient's treatment outcome ¹.

That's why Ryzneuta (efbemalenograstim alfa)'s approval in China and the USA within 2023 was good news for all cancer patients undergoing chemotherapy. At the same time, for those based outside of China and the USA, the question remains - when will Ryzneuta be available?

Here's everything you need to know about Ryzneuta's approval status in Europe and the UK. Including your options for accessing the medicine quickly.

What is Ryzneuta used for?

Ryzneuta helps decrease the risk of infection in adults with non-myeloid malignancies, who are receiving myelosuppressive anti-cancer treatment associated with febrile neutropenia ².

Ryzneuta increases the number of white blood cells, known as neutrophils, to strengthen the immune system's ability to fight infection and reduce the risk of infections. Its mechanism of action involves binding to the granulocyte colony-stimulating factor (G-CSF) receptor, resulting in an increase in the number and survival of neutrophils ³.

When is Ryzneuta being launched in Europe?

This is an important and interesting question to ask. Especially since the marketing authorization application for the medicine was accepted by the EMA already back in October 2021 ⁴. Typically, the EMA's application review process takes 210 active days, and can be paused to ask additional questions to the manufacturer.

However, in the case of Ryzneuta, there seems to be no ongoing application review, or a record of the application on the EMA website. In this context, it doesn't seem likely that Ryzneuta will be available in the EU in the foreseeable future.

When is Ryzneuta being launched in the UK?

At the moment, there is no ongoing evaluation of Ryzneuta by either the MHRA or NICE. If Ryzneuta's manufacturer submits an authorization application to the MHRA, it typically takes 90 days to process. Once MHRA-approved, the NICE needs to evaluate the medicine as well for NHS coverage. In case of a positive recommendation by NICE, Ryzneuta can be made available on the NHS within 3 months ⁵.

With these timelines in mind, it seems that cancer patients in the UK are unlikely to have access to Ryzneuta soon.

How to access Ryzneuta before its EMA approval

Has your cancer treatment been delayed due to neutropenia? Then the last thing you want to hear is that you need to wait some more until Ryzneuta can be available to you as a neutropeania treatment. The good news is, you don't have wait.

You have two options to safely and quickly access Ryzneuta before it's widely available in Europe or the UK. The first option is locating and joining an ongoing clinical trial with Ryzneuta. The other option is to buy Ryzneuta immediately as an Individual Named Patient.

Join a Ryzneuta clinical trial

You can try joining an ongoing clinical trial to get quick access to Ryzneuta (efbemalenograstim alfa). Finding trials isn't easy, but it's possible, and there are multiple platforms to help you (some listed below). To participate, you must meet the eligibility criteria and have your doctor's support. Be aware that you might receive a placebo instead of the active ingredient.

Here are some good places to start looking for ongoing Ryzneuta 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. At the moment, there are no listed clinical trials involving nitrogacestat. However, this can change at any point, so it's worth keeping an eye on.
• 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 and FindMeCure: Both organizations support patients in finding treatment options in clinical trials.

Buy Ryzneuta as an Individual Named Patient

Most countries in the world allow for individual patients to import medicines that can address serious conditions before they are available locally. The regulation guiding this process is referred to as the Named Patient Import regulation.

If you want to buy Ryzneuta before its EMA approval or UK approval, this could be a good option for you and your doctor.

To make use of the Named Patient Import regulation, you will need a prescription from your doctor. Based on your country, additional documentation may be required.

Buy Ryzneuta

If you have a prescription for Ryzneuta and would like to buy the medicine right now, get in touch with us. Our team at Everyone.org is qualified and certified to support you with importing medicines before they're locally available.

References:

1. Neutropenia: A side effect cancer patients should work to prevent, especially during a pandemic. Cancer Treatment Centers of America, 18 January 2021.
2. Prescribing information, Accessdata.fda.gov, Accessed 15 January 2024.
3. Puckey, Melisa. Ryzneuta: Uses, Dosage, Side Effects, Warnings. Drugs.com, 27 November 2023.
4. Evive Biotech\'s Ryzneuta Marketing Authorization Application Accepted for Review by European Medicines Agency. CMOCRO, Accessed 15 January 2024.
5. Ewbank, Leo. Access to new medicines in the English NHS. The King's Fund, 28 October 2020.