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USFDA Grants Approval to Ipsen and Genfit's Drug to Treat Chronic Inflammatory Liver Disease

USFDA Grants Approval to Ipsen and Genfit's Drug to Treat Chronic Inflammatory Liver Disease

The French pharmaceutical companies Ipsen and Genfit received fast approval from the US Food and Drug Administration (USFDA) for their medication to treat chronic inflammatory liver disease.

The tiny bile channels in the liver become inflamed and subsequently destroyed by primary biliary cholangitis (PBC). In the US, the condition affects 75,000 people, mostly women between the ages of 30 and 60.

Obeticholic acid, marketed under the trade name Ocaliva, is presently licenced for use in PBC patients as a single treatment in those who cannot take ursodeoxycholic acid (UDCA), or in conjunction with UDCA.

According to this permission, the Genfit-Ipsen medication may also be administered in conjunction with UDCA or, in cases where UDCA is intolerable, alone.

The approval of Iqirvo was predicated on findings from a late-stage trial including 161 patients, whereby the medication considerably decreased the levels of alkaline phosphatase, an enzyme that, at excessive concentrations, can cause liver damage.

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More news about: global pharma | Published by Manvi | June - 14 - 2024 | 190

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