Amicus Therapeutics, Inc. (NASDAQ: FOLD) has received a patent from the USPTO for migalastat. The patent, which expires in 2038, covers a compound with migalastat and is bound to alpha-galactosidase A protein.
According to the CEO and Chairman of Amicus, John F. Crowley, the company was excited after receiving the USPTO patent. It adds to its growing intellectual property and allows it to commercialise its product.
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The company developed the drug no Fabry disease with GLA variants
Crowley adds that the news is a testament to the company’s hard work, dedication, and expertise of its team. Moreover, it shows that the considerable investment Amicus made has paid off. In addition, this product will allow the company to help Fabry disease patients with GLA variants.
The patent is among the many that Amicus has for migalastat. The oral drug stabilises Alpha Gal-A and clears the diseased substrate from the body. This drug gives the company a way to treat a disease which affects millions of people globally.
Between 35% and 50% of Fabry disease patients have amenable GLA variants. However, the extent depends on factors like geography. The drug has received approval from various regulators allowing Amicus to make it in Japan, the U.K, E.U, and the U.S.
Amicus developed the drug from adults with Fabry disease with GLA variants. The U.S FDA and other regulators approved it based on accelerated approval after a successful test in vitro. The drug could receive further approval if Amicus displays its benefits after a clinical trial.
There is no evidence of its effect on pregnant women
Amicus has found that the drug causes pyrexia, nausea, UTI, nasopharyngitis, and headache. Furthermore, the company hasn’t provided enough information on its use in expectant women. For this reason, physicians have to warn expectant mothers of the risk of miscarriage and congenital disabilities.
There is also little evidence on its effect on infants and its passage to breastmilk. For this reason, healthcare workers have to advise breastfeeding mothers on the use of migalastat carefully. They should also avoid giving them the drug unless necessary.
The E.U has also advised patients to only accept the drug from specialists who know how to work with Fabry disease. Moreover, patients who have no amenable GLA should avoid the medication.