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Italian company Leadiant was fined 19,569,500 euros (approximately $ 23 million) for unfair trade.
This has been determined by the Dutch regulatory body for medicines.
It was the Dutch Consumers and Markets Authority that handed down its judgment against the Italian company for abusing its dominant position in the market and selling its drug CDCA-Leadiant at an inflated price.
The remedy contains chenodeoxycholic acid, which is used to treat patients with cerebrotendinous xanthomatosis (CTX), a rare inherited metabolic abnormality that causes irreparable damage due to the build-up of fatty acids in different parts of the body.
“In the Netherlands, around 60 people currently suffer from this disease and have to take chenodeoxycholic acid for the rest of their lives. Whereas previously the drug, which had no equivalent therapeutic alternative, was available at various affordable prices, the situation changed dramatically when Leadiant became the only manufacturer authorized to sell it on the European market ”, publishes l agency Rt.
In 2008, the price of the drug was 46 euros ($ 54) for 100 capsules. At the end of 2009, Leadiant changed its trade name and raised the price to 885 euros ($ 1,044). While in 2014, chenodeoxycholic acid cost 3,103 euros ($ 3,661)
At that time, the pharmaceutical company had asked to call it “orphan drugs”, which were intended to treat a rare disease that affects a small group of patients.
In 2017, the company Leadiant went further: it obtained the exclusive right to distribute the drug on the European market for 10 years and traded the drug in the Netherlands with an identical one under a different trade name, CDCA-Leadiant, by selling it for 14,000 euros ($ 16,524).
Thus, in nearly 10 years the increase in the price of chenodeoxycholic acid in the country made up more than 30,000%. “As a result, the drug costs around 153,000 euros per patient per year,” concluded the Consumers and Markets Authority.
The high price caused a public outcry and the situation remained unchanged until January 2020, when the Amsterdam University Medical Center managed to produce the drug on its own premises.
Acm.nl, Rt.
.
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