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A panel of independent FDA advisers is meeting today to consider the merits of Spark Therapeutics’ (ONCE) Luxturna, a one-time gene therapy meant to treat a rare, inherited form of childhood blindness.

If the panel votes yes and the FDA follows its recommendation, Luxturna would become the first therapy meant to replace or repair a defective gene approved in the U.S. Spark hasn’t disclosed pricing, but analysts estimate Luxturna could cost $1 million or more per patient, a price that might force payers and insurers to rethink their coverage and reimbursement models.


STAT’s Adam Feuerstein is watching Thursday’s Luxturna advisory panel and will be posting updates throughout the day. STAT Plus subscribers can also tune in at 3:30 pm ET for a live chat in which Adam and Damian Garde will break down the panel’s vote and take your questions. You can read a preview of today’s Spark FDA panel here.

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