Mirum falls as FDA expands label for Ipsen’s liver disease therapy
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The FDA’s decision to expand the label for liver disease therapy Bylvay from French pharma Ipsen (OTCPK:IPSEY) (OTCPK:IPSEF) pressured the U.S. biotech Mirum Pharma (NASDAQ:MIRM) – which markets a rival therapy – on Wednesday.
Livmarli, Mirum’s (MIRM) only FDA-approved product, is indicated in the U.S. to treat cholestatic pruritus in patients aged three months and older with the rare genetic disorder Alagille syndrome (ALGS).
On Tuesday, Ipsen (OTCPK:IPSEY) announced that FDA approved Bylvay as a once-daily regimen for the same indication in those aged 12 months and above.
The treatment, also known as odevixibat, was first launched in 2021 after the U.S. cleared it for cholestatic pruritus in patients with the liver condition progressive familial intrahepatic cholestasis (PFIC).
Commenting on the latest FDA nod for Bylvay, Citi analyst David Lebowitz argued that for those under 12 months of age with ALGS, Livmarli remains the only option.
The decision “increases the competition in an already modest ALGS market,” Lebowitz added while arguing that Mirum (MIRM) might have an advantage as the condition is often diagnosed within the first year of one’s life.
Currently, Bylvay is approved in the U.S. for PFIC in patients aged six months or older, and the company awaits EU approval for the product in H2 2023 for ALGS.