Fierce Pharma March 20, 2024
After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy (MLD) in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have broken new boundaries in pricing, too.
Orchard—which was bought by Japan’s Kyowa Kirin for $387.4 million in October—has set the wholesale acquisition cost for its one-time gene therapy at $4.25 million, making Lenmeldy the most expensive drug in the U.S.
Until now, that title was held by CSL Behring and uniQure’s hemophilia B gene therapy Hemgenix, which passed muster with U.S. regulators in November 2022 and carries a $3.5 million price tag before discounts.
Lenmeldy’s steep cost is “reflective of the value the therapy may deliver … as well...
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