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Home » Jacobus Seeks Supreme Court Decision on Orphan Drug Legal Battle
Jacobus Seeks Supreme Court Decision on Orphan Drug Legal Battle
April 22, 2022
In a last-ditch legal action, Jacobus Pharmaceutical has asked the Supreme Court to review a lower court’s decision over its Lambert-Eaton myasthenic syndrome (LEMS) drug, Ruzurgi (amifampridine), for the treatment of pediatric patients.
The FDA approved the drug in May 2019 for pediatric use but withdrew its approval in February of this year after a federal appeals court overturned the agency’s approval.
The court ruled that the FDA incorrectly approved Ruzurgi because Catalyst Pharmaceuticals owned the rights to the drug and had orphan drug exclusivity for its product, Firdapse, which is approved for the treatment of adults.
The FDA’s controversial approval of Ruzurgi for pediatric use meant that doctors could prescribe Jacobus’ less-expensive version of the treatment for all patients, with adults getting prescribed the drug off-label.
Ruzurgi, which was dosed according to the patient’s body weight, cost up to $100,000 per year, while the list price for Firdapse is more than three times higher.
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