Firdapse Now Widely Available in Canada for Treating LEMS, KYE Pharmaceuticals Says

Firdapse (amifampridine) is now widely available in Canada as a treatment for adults with Lambert-Eaton myasthenic syndrome (LEMS), according to KYE Pharmaceuticals, which markets the oral therapy.

Health Canada, the country’s medicines regulatory agency, approved Firdapse, sold as a 10 mg tablet, earlier this year.

“As the commercial partner for FIRDAPSE in Canada, this is a highlight for KYE and for those Canadian patients suffering from LEMS,” Doug Reynolds, KYE’s president, said in a press release.

To ensure access to the medication to everyone who needs it, KYE is launching the Firdapse Patient Support Program. It is designed to help patients navigate reimbursement, and transition to Firdapse from another amifampridine therapy as smoothly as possible. Enrolled patients also may receive financial assistance to ensure timely access to the medicine.

LEMS occurs when autoantibodies — immune proteins that mistakenly target the body’s own tissues or organs — attack voltage-gated calcium channels (VGCC) found at the end of nerve cells. Normally, the uptake of calcium ions by nerve cells leads to the release of acetylcholine, a chemical messenger that induces muscle contraction.

Firdapse works by blocking another channel found on nerves, called the voltage-dependent potassium channel. This opens any remaining VGCCs and promotes muscle function.

The therapy was originally developed by BioMarin Pharmaceuticals, which in 2012 granted Catalyst Pharmaceuticals exclusive rights for Firdapse’s development and commercialization in North America.

KYE, a Canadian-based company, recently reached an agreement with Catalyst to market the medicine throughout Canada.

Under the agreement, Catalyst will provide the supplies of Firdapse and KYE will manage all marketing aspects for the medication, including its advertising, promotion, importation, distribution, and sales. All regulatory information related to Firdapse in Canada will be maintained by KYE, which also will handle communications with Health Canada.

“KYE is proud to be a partner in the treatment of neuromuscular diseases in Canada and is committed to supporting both patients and specialists in the treatment of LEMS with FIRDAPSE,” Reynolds said.

Firdapse is the second oral amifampridine product to be made available in Canada, following the approval of Ruzurgi in September. With its approval in Canada, Firdapse guaranteed that no generic version will enter the market for eight years. All eligible LEMS patients requiring treatment with Firdapse will receive the therapy, said KYE.

The treatment also is currently available in the U.S., the European Union, and elsewhere.