Movectro: Withdrawal of the marketing authorisation application

Movectro is a medicine that contains the active substance cladribine. It was to be available as tablets.

Movectro was expected to be used to treat the type of multiple sclerosis (MS) known as 'relapsing-remitting' MS. It was originally expected to be used in patients with high disease activity or in patients who did not tolerate beta-interferon or glatiramer acetate (other medicines used to treat MS). During the evaluation, this was subsequently restricted to patients with high disease activity or patients with persistent disease activity despite treatment with other medicines.

MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells, leading to a range of neurological symptoms such as numbness, impaired coordination and balance, weakness, vision and speech impairment. MS is described as 'relapsing-remitting' when the patient has attacks (relapses) in between periods with no symptoms (remissions).

The active substance in Movectro, cladribine, has been used in anti-cancer medicines since the mid-1990s. Cladribine has a similar structure to purine, one of the substances that make up DNA. In MS, it is expected to work within the lymphocytes (a type of white blood cell) which are involved in the inflammation seen in MS. Cladribine takes the place of purine and interferes with the normal production of new DNA in these cells, preventing them from multiplying, leading to death. This is expected to help reduce inflammation, thereby improving symptoms of the disease.

The active substance in Movectro, cladribine, has been used in anti-cancer medicines since the mid-1990s. Cladribine has a similar structure to purine, one of the substances that make up DNA. In MS, it is expected to work within the lymphocytes (a type of white blood cell) which are involved in the inflammation seen in MS. Cladribine takes the place of purine and interferes with the normal production of new DNA in these cells, preventing them from multiplying, leading to cell death. This is expected to help reduce the inflammation, thereby improving the symptoms of the disease.

The effects of Movectro were first tested in experimental models before being studied in humans. The company presented the results of one main study that compared Movectro with placebo (a dummy treatment) in 1,326 patients with relapsing-remitting MS. The main measure of effectiveness was the number of relapses the patients had during the 24 months of treatment. The study also looked at how long it took for the patient's disabilities to get worse.

The evaluation had finished and the CHMP had given a negative opinion, which had been confirmed following a re-examination procedure. The company withdrew after this opinion.

Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Movectro for the treatment of relapsing-remitting multiple sclerosis. The CHMP had concerns about the medicine's safety, and these concerns were not resolved during the re-examination procedure. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Movectro did not outweigh its risks.

The letter from the company notifying the Agency of the withdrawal of the application is available under the tab 'All documents'.

The company informed the CHMP that it intends to continue clinical trials with Movectro. Patients involved in such trials should contact their doctor if they have any questions. The company also stated that in all trials with Movectro, an independent data safety monitoring board monitors the safety and efficacy data on a regular basis and has the right and the duty to propose study discontinuation for reasons related to a lack of anticipated benefit or unacceptable safety risk.