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NEW GENE THERAPY TO COST $4.25M — THE HIGHEST DRUG PRICE IN US
Paige Twenter - 16 hours ago
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The most expensive drug in the U.S. is now Lenmeldy, a $4.25 million gene
therapy the FDA approved March 18 for children with a rare genetic disease.
Metachromatic leukodystrophy manifests into the loss of motor and cognitive
function, and early death, according to the FDA. The first and only one-time
medicine for patients is Lenmeldy (atidarsagene autotemcel). Its manufacturer,
Orchard Therapeutics, said the drug's wholesale acquisition cost is $4.25
million.
In a March 20 news release, Orchard said the price tag "is reflective of the
value the therapy may deliver to eligible patients and their families, as well
the potential long-term impact [the] treatment may have on overall healthcare
utilization, minimization of productivity loss for caregivers and life
opportunities for patients."
In a trial, 37 children received Lenmeldy and experienced a significant
reduction in the risk of severe motor impairment and death compared to untreated
children. At 5 years old, 71% of treated children could walk without assistance.
All study participants who had pre-symptomatic late infantile MLD were alive at
6 years old, compared to 58% of children in the control group.
Before its approval, the Institute for Clinical and Economic Review said the
drug would be cost effective if priced between $2.3 million and $3.9 million.
Other chart-topping medications include Hemgenix, a $3.5 million hemophilia B
therapy; Elevidys, a $3.2 million muscular dystrophy drug; and Skysona, a $3
million medicine for adrenoleukodystrophy, according to CNN.
Subscribe to the following topics: fdadrugchildrenusapproved
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