2nd Firdapse Patent Secured in US by Catalyst with 3 Still Pending

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by Marisa Wexler MS |

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Catalyst Pharmaceuticals has secured a second U.S. patent covering Firdapse (amifampridine), an approved oral treatment for Lambert-Eaton myasthenic syndrome (LEMS).

“We are pleased that this second patent for Firdapse has been issued and believe that it further enhances our intellectual property protection for Firdapse,” Patrick J. McEnany, chairman and CEO of Catalyst, said in a press release.

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Catalyst secured its first patent for Firdapse last year. The new patent (No. 11,060,128), “Methods of administering 3,4-diaminopyridine,” covers the use of suitable doses of the medication to treat people with LEMS who are slow to metabolize, or process, amifampridine — the therapy’s active ingredient.

The new patent “is directed to innovative methods of administering amifampridine to slow metabolizers of amifampridine for the treatment of LEMS,” said Steven Miller, PhD, Catalyst’s chief operating officer and chief scientific officer.

The company will submit a request to the U.S. Food and Drug Administration for the new patent be listed in the agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the FDA’s Orange Book), Miller said.

The new patent is the first of four to be issued, and Catalyst is “cautiously optimistic that the U.S. Patent and Trademark Office will find the other pending patents allowable as well,” Miller added.

LEMS is caused by the body’s immune system wrongly attacking certain calcium channels on nerve cell endings, rendering these cells less able to release acetylcholine, a signaling molecule that plays a key role in muscle contraction. Ultimately, this leads to muscle weakness and other typical symptoms of LEMS.

Firdapse is designed to promote the function of any remaining healthy calcium channels on nerve cell endings, thereby increasing the release of acetylcholine with the end goal of improving muscle function.

The medication is available in 10 mg tablets, with doses tailored based on each individual’s needs.

Treatment with Firdapse has been shown in clinical trials to improve muscle strength, as well as quality of life and several measures of physical function, in people with LEMS.

Firdapse was approved in the U.S. in 2018 to treat people, 17 and older, with LEMS. It has also been approved for the same indication in the European Union and Canada. Catalyst is working to secure regulatory approvals elsewhere.