Amversio

Amversio can only be obtained with a prescription. Treatment with Amversio should be supervised by a doctor who has experience in the treatment of patients with homocystinuria.

Amversio is available as a powder to be taken by mouth. It should be dissolved fully in water, juice, milk, formula or food before being taken. The standard dose of Amversio is 50 mg per kilogram of body weight twice a day. The dose can be adjusted depending on the response to treatment (monitored by measuring the level of homocysteine in the blood). The aim of the treatment is to keep blood levels of homocysteine below 15 micromoles or as low as possible. This is usually achieved within a month.

For more information about using Amversio, see the package leaflet or contact your doctor or pharmacist.

Betaine is a natural substance that is extracted from sugar beet. It reduces the high homocysteine levels in the blood of patients with homocystinuria by transforming homocysteine into the amino acid methionine. This helps to improve the symptoms of the disease.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Cystadane, and do not need to be repeated for Amversio.

As for every medicine, the company provided studies on the quality of Amversio. There was no need for ‘bioequivalence’ studies to investigate whether Amversio is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Amversio is a water-soluble medicine with a composition very similar to the reference medicine’s and both products are therefore expected to be absorbed in the same way in the gut.

Because Amversio is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Amversio has been shown to be comparable to Cystadane. Therefore, the Agency’s view was that, as for Cystadane, the benefits of Amversio outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amversio have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Amversio are continuously monitored. Suspected side effects reported with Amversio are carefully evaluated and any necessary action taken to protect patients.

Amversio received a marketing authorisation valid throughout the EU on 5 May 2022.