Teva’s Galafold generic for Fabry disease may be available in US
Clearance expected by January 2037, pending FDA approval
Amicus Therapeutics and Teva Pharmaceuticals have struck a deal that will allow the latter to sell a generic version of Galafold (migalastat), Amicus’ chaperone therapy for Fabry disease, to patients in the U.S.
Under the agreement, Teva will have its clearance on Jan. 30, 2037, assuming the U.S. Food and Drug Administration (FDA) approves the company’s generic therapy and that no other issues arise in the meantime.
The generic version should have the same active ingredient, strength, route of delivery, safety, efficacy, and intended use as its brand-name alternative. Generic medicines usually come at a significantly lower cost, however.
The settlement “is a major step forward in ensuring Amicus can continue to support the Fabry community with Galafold for many years to come,” Bradley Campbell, president and CEO of Amicus, said in a company financial update.
Amicus and Teva have been engaged in a legal dispute since 2020 when Teva accused Amicus of refusing to provide access to enough Galafold samples for studies that could determine the equivalence of Teva’s generic formulation.
While the dispute ended the following year, Teva submitted an application to the FDA in 2022 seeking approval of its Galafold generic before Amicus’ patents on the medication had expired.
Moving forward
With the new agreement, which was finalized in October, all litigation between the two companies has ended. Amicus is still engaged in a separate dispute with Aurobindo Pharma due to a similar issue, however.
Fabry disease is caused by mutations in the gene that encodes alpha-galactosidase A (Gal A), an enzyme essential for breaking down certain fatty molecules. Without a working version of the enzyme, fatty molecules build up to toxic levels inside cells, leading to the organ damage that drives Fabry symptoms.
Galafold is a chaperone therapy that’s designed to bind to the defective Gal A enzyme and stabilize it so it can function better, thereby allowing fatty molecules to clear, slowing the disease’s progression.
Taken once daily, the oral medication has been approved in the U.S. for Fabry patients with certain types of disease-causing mutations since 2018. It’s also cleared in the European Union and other markets around the world. It carries a list price of $315,000 per year.
“Amicus continues to be well positioned to drive sustainable shareholder value and further our mission of delivering great medicines for people living with rare diseases,” Campbell said.
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