Leadiant has taken note of the announcement of the Netherlands Authority for Consumers and Markets (ACM) to impose a fine regarding the medicinal product Chenodeoxycholic acid (CDCA) Leadiant.

Leadiant fundamentally disagrees with the allegations in the announcement. Antonio Gama da Silva, CEO at Leadiant Biosciences, Ltd. said: “We are committed at Leadiant to making a difference in the lives of patients with rare diseases. We believe that patients suffering from rare diseases deserve a treatment with the same safety, efficacy and quality as other patients, with products that are specifically authorised for the treatment of their disease after a thorough assessment by the competent authorities. We are convinced that we have always acted correctly and in compliance with all applicable regulations.”

The decision raises several questions. For example, the ACM states that Leadiant had 100% market share even during the period April 2018 - August 2018, when Leadiant's product was removed from the market and an unauthorised pharmacy compounded product was reimbursed instead. Moreover, Leadiant’s product was permanently removed from the market in January 2020, just after the period investigated by the ACM.

Leadiant will now thoroughly review ACM's assessment and decision and will challenge it.