EU Ocaliva Withdrawal Recommendation Based On ‘Flawed’ Studies

 
• By Francesca Bruce
  
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Overreliance on “problematic” trials while overlooking the value of real-world evidence could affect the development of other rare disease treatments, according to Advanz’s CEO.

PBC
There are around 7,000 PBC patients in the EU • Source: Shutterstock

Advanz Pharma is urging the European authorities to consider the “thousands” of primary biliary cholangitis (PBC) patients in the EU who will be left without treatment if the European Commission withdraws the conditional marketing authorization for its rare disease drug, Ocaliva (obeticholic acid), on the basis of a recommendation from the European Medicines Agency, according to Steffen Wagner, Advanz’s chief executive officer.

He said the recommendation relied too much on a “flawed and unethical” obligatory randomized placebo controlled trial and did not...

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