Amifampridine SERB

Amifampridine Serb can only be obtained with a prescription and treatment with this medicine should only be started under the supervision of a doctor experienced in treating LEMS.

The recommended starting dose of Amifampridine Serb is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day. Amifampridine Serb is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Amifampridine Serb should be taken with food.

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

For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine. Acetylcholine is released from the nerve endings during a period of ‘depolarisation’. The active substance in Amifampridine Serb, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells. This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract.

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

As for every medicine, the company provided data on the quality of Amifampridine Serb. There was no need for ‘bioequivalence’ studies to investigate whether Amifampridine Serb is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Amifampridine Serb is the same as the reference medicine and the active substance in both products is expected to be absorbed in the same way.

Because Amifampridine Serb 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, Amifampridine Serb has been shown to be comparable to Firdapse. Therefore, the Agency’s view was that, as for Firdapse, the benefits of Amifampridine Serb 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 Amifampridine Serb have been included in the summary of product characteristics and the package leaflet.

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

Amifampridine Serb received a marketing authorisation valid throughout the EU on 19 May 2022.