HQ Team
June 12, 2024: The US drug regulator has granted accelerated approval for a drug to treat chronic inflammatory liver disease to Genfit, headquartered in Nord, France, and Paris-based Ipsen, according to the companies.
Iqirvo (elafibranor), the drug, is meant to treat primary biliary cholangitis — an autoimmune disorder that leads to the gradual destruction of intrahepatic bile ducts, resulting in periportal inflammation and cholestasis or a decrease in bile flow.
Prolonged hepatic cholestasis subsequently causes cirrhosis and portal hypertension. Primary biliary cholangitis is the most common cholestatic disease of middle-aged women in the US.
The approval by the US Federal Drug Administration was based on the reduction of alkaline phosphatase. “Improvement in survival or prevention of liver decompensation events has not been demonstrated.”
Cirrhosis
Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials, according to Genfit.
“Iqirvo is not recommended for people who have or who develop decompensated cirrhosis” such as ascites, variceal bleeding, and hepatic encephalopathy.
Genfit will receive about €48.7 million in payments from Ispen upon the first commercial sale of Iqirvo in the US, as well as tiered double-digit royalties up to 20%, according to a Genfit statement.
“A €13.3 million milestone payment which was invoiced in December 2023, and received in February 2024.”
Long-term pact
Ipsen and Genfit entered into a long-term strategic partnership for global collaboration on December 17, 2021. Ipsen is the largest shareholder in Genfit holding 8% of the equity.
The agreement gives Ipsen an exclusive worldwide license to develop, manufacture and commercialise Genfit’s investigational treatment elafibranor for people living with primary biliary cholangitis.
The partnership also gives Ipsen access to future clinical programs led by Genfit and combines Genfit’s scientific expertise and proprietary technologies in liver disease with Ipsen’s development and commercialisation capabilities.
New liver disease drugs
Elafibranor will be marketed and commercialized by Ipsen under the trademark Iqirvo and may be prescribed immediately in the US for eligible patients, according to the statement.
“We took elafibranor (Iqirvo) all the way from drug discovery to the end of Phase 3 and now, thanks to our partnership with Ipsen, it will be made available to healthcare providers in the US and ultimately provide patients with a valuable therapeutic alternative,” said Pascal Prigent, CEO of Genfit.
“We expect that the revenues derived from the commercialisation of elafibranor will now finance the development of a new and exciting portfolio of programs focused on ACLF,” or Acute on-Chronic Liver Failure and other diseases, he said.
