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Ruzurgi Approval History

Reviewed by J.Stewart BPharm Last updated on May 22, 2019.

FDA Approved: Yes (First approved May 6, 2019)
Brand name: Ruzurgi
Generic name: amifampridine
Dosage form: Tablets
Company: Jacobus Pharmaceutical Company Inc.
Treatment for: Lambert-Eaton Myasthenic Syndrome

Ruzurgi (amifampridine) is a potassium-channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years to less than 17 years of age.

  • Ruzurgi is the first treatment approved specifically for LEMS in pediatric patients.
  • Amifampridine was also approved under the brand name Firdapse (amifampridine phosphate) in November 2018 as a treatment for LEMS in adults.
  • The $375,000 per year price tag that came with Catalyst Pharmaceuticals' Firdapse sparked outrage among LEMS patients, as they had previously been able to access the drug for free through an FDA compassionate use program.1
  • Ruzurgi is expected to be available at a much lower cost than Firdapse.
  • Although Ruzurgi is approved for use in pediatric patients, the FDA decision does make it possible for physicians to prescribe the drug off-label to adults.
1. Senator Sanders asks why drug, once free, now costs $375k Accessed May 21, 2019 at https://www.reuters.com/article/us-usa-healthcare-catalyst/senator-sanders-to-ask-why-drug-once-free-now-costs-375k-idUSKCN1PT0ZJ

Development History and FDA Approval Process for Ruzurgi

DateArticle
May  6, 2019Approval FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome

Further information

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