Kris Kowdley, MD, contributed significantly to the clinical research program that led to accelerated FDA approval of Ipsen’s Iqirvo, a first-in-class treatment for primary biliary cholangitis (PBC), a rare liver disease. As a primary investigator for the Phase 3 ELATIVE trial, Dr. Kowdley’s site enrolled the first patient in the study, and he was the lead author of the pivotal study results published in the New England Journal of Medicine.
In the press release announcing the approval, Dr. Kowdley stated, “The approval of Iqirvo will allow healthcare providers in the U.S. to address an unmet need with the potential to significantly reduce ALP levels for our patients with PBC.”
Congratulations to Ipsen, Dr. Kowdley, the team in Seattle, and all the clinical trial participants involved for driving this major advancement in PBC treatment!
Read the full press release: https://www.ipsen.com/press-releases/ipsens-iqirvo-receives-u-s-fda-accelerated-approval-as-a-first-in-class-ppar-treatment-for-primary-biliary-cholangitis/
