Orchard sets $4.25M price for gene therapy Lenmeldy in US

Orchard Therapeutics’ ultra-rare disease drug Lenmeldy is vaulting to the list of most expensive drugs ever with a wholesale acquisition cost of $4.25 million for the one-time treatment in the US.

The company announced the price Wednesday following Lenmeldy’s FDA approval earlier this week, saying that it reflects “its clinical, economic and societal value.”

Lenmeldy is the only FDA-approved treatment for children with early-onset metachromatic leukodystrophy, a rare neurometabolic disease that affects an estimated fewer than 40 children annually in the US, according to Orchard. The gene therapy was approved as Libmeldy in the EU in 2020 and in the UK in 2022, where it has a list price of £2.8 million. Libmeldy has already generated $12.7 million in sales in the first nine months of 2023, according to Orchard’s last earnings report.

In justifying the price tag, Orchard said that it referenced the Institute for Clinical…
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