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(CercleFinance.com) – Ipsen announces that the European Commission has granted conditional marketing authorization to Iqirvo (elafibranor), a new first-in-class treatment for primary biliary cholangitis (PBC), a rare liver disease.
The product was conditionally approved for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients intolerant to UDCA.
‘The approval follows the positive opinion issued by the CHMP based on data from the phase III ELATIVE trial, which demonstrated significant efficacy compared to placebo as well as an acceptable safety profile,’ the laboratory specifies.
This decision, which makes Iqirvo the first new treatment for PBC in nearly a decade, ‘reinforces Ipsen’s commitment to developing innovative treatments for people with rare cholestatic liver diseases.’
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