Fda approves the listing of the ruzurgi (amifampridine) pill
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Last Update: 2021-02-16
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Source: Internet
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Author: User
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LEMS is a rare autoimmune disease that affects connections between nerves and muscles, leading to muscle weakness and other symptoms in patients. LeMS patients' own immune systems attack neuromuscular joints (neuromuscular junctions, NMJ), blocking nerve signaling to muscle cells.
today, the FDA announced approval for the launch of Jacobus Pharmaceutical's Amifampridine pill for the treatment of patients aged 6-17 with Lambert-Eaton muscle weakness syndrome (LEMS).
Ruzurgi's approval is based on clinical trials in adult LEMS patients (pharmacodynamic data for adult patients, as well as paediatric patient doses found using pharmacodynamic models and simulations, and safety data obtained from pediatric patients aged 6-17 years).
ruzurgi was based on a randomized double-blind, placebo-controlled clinical study of 32 adult patients. In the study, patients were treated with Ruzurgi for three months, followed by some patients who continued to use Ruzurgi, and others who were treated with a placebo.The results showed that patients who continued to receive Ruzurgi had less motor capacity than the placebo group. (Drug Information Network)
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