The U.S. Food and Drug Administration has approved the French drugmaker Ipsen’s medication Iqirvo (elafibranor). Doctors discuss what this means for liver disease patients.
A new drug to control liver disease has gotten the green light. The U.S. Food and Drug Administration has approved the French drugmaker Ipsen’s medication Iqirvo . The drug, an 80 mg tablet administered orally once daily, is intended to treat an autoimmune cholestatic liver disease called primary biliary cholangitis . What is PBC? PBC is a disease in which the immune system attacks and destroys the small bile ducts of the liver.
Many people — mostly women — have elevated liver enzymes that can be easily diagnosed with a simple blood test called the AMA.' Patients typically experience severe fatigue and significant itching called pruritus. If the disease is not treated or an individual does not respond to current therapies, it can lead to liver failure, the need for a liver transplant or even early death, according to experts. PBC is diagnosed with a blood test that measures liver enzymes.
The approval of Iqirvo will allow health care providers in the U.S. to address an unmet need, with the potential to significantly reduce ALP levels for our patients with PBC,' he added. Continued approval is contingent upon further studies showing improved survival or prevention of liver decomposition, the FDA report noted.
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