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Details:
Firdapse (amifampridine) is a broad spectrum potassium channel blocker. sNDA submission has been planned to increase indicated maximum dose for firdapse® from 80 mg per day to 100 mg per day for the treatment of lambert eaton myasthenic syndrome ("LEMS").
Lead Product(s): Amifampridine
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2023
Details:
Supplemental New Drug Application ("sNDA") to expand the indicated age range for FIRDAPSE® (amifampridine) Tablets 10 mg to include pediatric patients, six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").
Lead Product(s): Amifampridine
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2022
Details:
Firdapse (amifampridine phosphate) is a broad spectrum potassium channel blocker. Amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Lead Product(s): Amifampridine
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DyDo Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
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