Generic Amifampridine SERB Wins EMA Endorsement To Treat LEMS

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A branch of the European Medicines Agency (EMA) has recommended that Amifampridine SERB, a generic version of Firdapse, be approved to treat adults with Lambert‑Eaton myasthenic syndrome (LEMS) in the European Union.

The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), will now be reviewed by the European Commission, which makes final decisions about whether to authorize treatments in all EU member states.

In LEMS, the body’s immune system erroneously launches an attack that interferes with the communication between nerve and muscle cells. Specifically, LEMS is driven by antibodies that target voltage-gated calcium channels (VGCCs), found on nerve cell endings.

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Under normal circumstances, calcium ions flowing through VGCCs into nerve cells help trigger the release of acetylcholine, a chemical messenger that instructs muscle cells to contract. However, in LEMS, the immune attack impairs VGCCs’ function and prevents nerve cells from releasing acetylcholine, resulting in muscle weakness and other disease symptoms.

Amifampridine, the active agent in Firdapse, works by blocking a different protein channel called the voltage-dependent potassium channel. By blocking this protein, the medication ensures that any remaining healthy VGCC proteins remain open, allowing more calcium to flow into nerve cells. This facilitates the release of acetylcholine and is expected to ease LEMS symptoms.

The new generic medication contains this same active ingredient, and will be available in tablets at the same 10 mg dose, as the name-brand medicine. Generics are medicines that are pharmacologically and biologically equivalent to name-brand medicines, but are made by different manufacturers. Since they introduce competition into pharmaceutical marketplaces, generics can help drive down treatment costs.

The new generic “has the same qualitative and quantitative composition in active substance and excipients, and the same pharmaceutical form as” the name-brand medicine, according to SERB, the pharmaceutical company developing it. The generic also “is manufactured following the same process and at the same manufacturing sites” as the name-brand product.

Firdapse is marketed by BioMarin Pharmaceutical in Europe. Its licensing rights in North America are owned by Catalyst Pharmaceuticals.