Amicus sets $315,000 price for new Fabry disease treatment

(Reuters) - Amicus Therapeutics FOLD.O on Monday set an average price of $315,000 per year for its newly approved Fabry disease treatment, a price it believes is below that of the main existing treatment in the United States.

Amicus Therapeutics sign is shown in this image released on August 13, 2018. Courtesy Amicus Therapeutics/Handout via REUTERS

Galafold - approved on Friday by U.S. regulators - is the first new Fabry disease treatment in the country in over 15 years, and will compete with Sanofi SA's SASY.PA infused Fabrazyme, which has an average U.S. list price of $340,000 for adults, according to Amicus.

Sanofi, however, says Fabrazyme’s price is closer to $290,000, when accounting for pediatric patients who tend to use less of the drug because of their weight. The French drugmaker did not detail drug prices separately for adults and children.

The list price of a drug is not necessarily what patients actually pay. “Out-of-pocket” costs vary based on the duration of the treatment and individual healthcare plans.

Galafold is an oral therapy for Fabry disease, a sometimes fatal genetic condition in which accumulation of fat damages several organs. An estimated 3,000 people in the United States are diagnosed with the disease.

Galafold will not have the additional costs of administering an infused drug like Fabrazyme, Amicus says.

The company is committed to keeping new treatments priced at parity with or slightly below existing treatments, it said on Monday.

“If we’re going to have more medicines for people living with rare diseases, we’ve got to bend the cost curve,” Chief Executive John Crowley said in an interview before Friday’s approval.

In Europe, where each country negotiates drug pricing, Galafold costs between $200,000 and $250,000 annually.

Amicus does not expect to raise Galafold’s U.S. price at a rate higher than consumer inflation, and has said it will use part of the drug’s revenue to develop new Fabry disease therapies.

Amicus shares rose 3.5 percent to $15.88 in trading before the bell on Monday.

Reporting by Robin Respaut in San Francisco and Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar