Breckenridge Gets FDA Approval of One Generic and Launches Two Others

The FDA has approved miglustat for Gaucher disease. Breckenridge launches pencillamine for Wilson’s disease and lacosamide for seizure disorder.

The FDA has granted final approval of Breckenridge Pharmaceutical’s abbreviated new drug application for miglustat capsules, a generic version of Janssen’s Zavesca, a therapy to treat mild-to-moderate type 1 Gaucher disease. The generic will be available in 100 mg strength and offered in a 90-count bottle. The company expects to launch miglustat capsules during the third quarter of 2022.

Gaucher is rare, genetic disorder caused by a mutation of the GBA gene, which impacts an enzyme that breaks down lipids. This causes a build up of lipids in the bone marrow, spleen and liver. Type 1 is the most common and symptoms include enlargement of the liver and spleen, anemia, lung disease and bone abnormalities.

Gaucher disease occurs in 1 in 50,000 to 100,000 people in the general population. Type 1 occurs more frequently in people of Ashkenazi Jewish heritage than in those with other backgrounds. This form of the condition affects 1 in 500 to 1,000 people of Ashkenazi Jewish heritage.

Additionally, Breckenridge has launched two generic therapies. The first one is pencillamine capsules, a generic for Bausch Health's Cuprimine, which is indicated to treat Wilson’s disease. The generic product was developed by Aggrega Pharma, and Breckenridge will market the product in its own label and offer the 250 mg strength in bottles of 100.

Wilson’s disease is an inherited disorder in which excessive amounts of copper build up in the liver, brain, and eyes. Liver disease is usually the first symptom of Wilson’s disease in affected children and young adults. It is a rare disorder that affects about 1 in 30,000 individuals.

The company has also launched lacosamide tablets, a generic version of UCB’s Vimpat, a therapy to treat patients with primary generalized tonic-clonic seizures. The generic product was developed and will be manufactured by MSN Laboratories and marketed by Breckenridge in the United States. Lacosmide are available in 50 mg, 100 mg, 150 mg and 200 mg strengths, and contained in bottle of 60 or 500 tablets.