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Antitrust regulators in Italy have fined a drugmaker nearly $3.8 million for years of “excessive” price hikes on a rare disease medicine, the latest instance in which European authorities have cracked down on the pharmaceutical industry for harming consumers and taxpayers.

At issue is a medicine known as CDCA that is used to treat people with cerebrotendinous xanthomatosis, or CTX, a rare genetic metabolic disease. A version was available for decades at a low cost. But the drug was bought by Leadiant Biosciences which, by 2014, began raising the price in several countries before withdrawing the medicine from the market entirely the following year.


However, the company brought the medication back to the market in 2017 after the European Medicines Agency designated CDCA as an orphan drug. The move gave the company 10 years of monopoly protection, although CDCA was not a new molecule. Orphan drug designations are meant to provide incentives to create new medicines for rare diseases.

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