More than three years after receiving approval in Europe, recent Kyowa Kirin Co., Ltd. acquisition Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) has finally won US Food and Drug Administration approval as well, for children with early-onset metachromatic leukodystrophy (MLD). Now, the task for the company is to roll the gene therapy out to a population of only a few dozen patients, with a price far in excess of what a drug pricing watchdog had expected.
Orchard Will Launch Lenmeldy At Just Five Centers
Gene Therapy Is World’s Priciest Drug
Orchard, which Kyowa Kirin bought in October, gave Lenmeldy a $4.25m list price, exceeding the upper bound of about $3.9m set by ICER.
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