The FDA has approved Zanvastro (zilganersen) injection to treat Alexander disease in pediatric and adult patients, making it the first FDA-approved treatment for the rare neurological disease.
Zanvastro is also the first therapy to directly target the protein buildup that drives Alexander disease, according to a Sept. 3 news release. The disease affects fewer than 1 in 1 million people and can cause seizures, loss of developmental milestones, difficulty walking, muscle weakness and increased pressure in the brain.
The drug is administered by injection into the spinal canal once every three months by a trained healthcare professional.
The FDA evaluated Zanvastro in a multicenter, randomized, controlled clinical study involving 49 pediatric and adult patients ages 2 and older, as well as an open-label substudy involving four patients younger than 2. Among patients ages 5 and older with measurable walking difficulties at baseline, those receiving Zanvastro had significantly better walking speed at 61 weeks than those receiving no treatment.
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