Posted from: Wednesday, May 16, 2018 - 04:38 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Tuesday, July 17, 2018 - 11:54 PM.