EMA recommends the revocation of the marketing authorisation for Adakveo
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended the cancellation of the marketing authorisation of Adakveo (crizanlizumab). The medicine prevents painful crises in patients aged 16 and older who have sickle cell disease.
Based on the CHMP assessment, it was found that the benefits of the medicine did not outweigh its risks. The assessment examined the results of the STAND study comparing Adakveo’s efficacy and safety with placebo in patients who had a history of painful crises leading to a healthcare visit. The study showed that Adakveo did not reduce the number of painful crises leading to a healthcare visit.
In terms of safety, the STAND study did not raise any new concerns, but it showed that Adakveo is causing more serious side effects. Therefore, the CHMP considered that the benefits of the medicine did not outweigh the risks.
Information for patients:
- A recent study has shown that Adakveo does not reduce the number of painful crises requiring a healthcare visit or treatment at home in patients with sickle cell disease.
- Because of the latest study results, Adakveo is being taken off the market in the EU and no new patients will be treated with the medicine.
- If you are receiving Adakveo treatment, make an appointment with your doctor at the next possible opportunity to discuss alternative treatments.
- If you have any questions, you should speak to your doctor, nurse or pharmacist.
- Jukka Sallinen, Head of Unit, tel. +358 29 522 3410
- Kari Punnonen, Head of Division, Senior Medical Officer, tel. +358 29 522 3440
- Fimea e-mail addresses are in the format email@example.com