Zavesca Generic Approved
April 17, 2018 – The U.S. FDA has approved Amerigen Pharmaceuticals’ generic form of Actelion’s Zavesca® (miglustat capsules). This is the first generic approved for Zavesca in the United States.
Miglustat is approved as a monotherapy to treat mild to moderate type 1 Gaucher disease in adult patients for whom enzyme replacement therapy is not a therapeutic option. A genetic disorder, Gaucher disease affects approximately one out of every 100,000 individuals. The condition causes excessive accumulation of glucocerebroside in the body, which may lead to difficulties that include enlargement of the spleen and liver, anemia, lung problems, skeletal disorders, and other serious complications. Type 1 Gaucher disease is the most common and mildest form of the disease, but symptoms and severity can vary significantly amongst individual patients.
Because miglustat can have serious side effects, including severe diarrhea and weight loss, it is not the preferred primary treatment for Gaucher disease. The drug works by inhibiting enzyme glucosylceramide synthase. This helps reduce the production of glucocerebroside in the body and reduce its accumulation. Recommended dosing is one 100mg capsule taken up to three times daily.
Amerigen Pharmaceuticals has not yet announced launch or pricing plans. In 2016, sales of Zavesca totaled roughly $107 million, as reported by Actelion.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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