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Spark Sets Sights On Bringing First Gene Therapy To Market In 2018

 
• By Jessica Merrill

A BLA for a potential gene therapy to correct vision loss due to certain inherited retinal disease has been accepted by FDA with a Jan. 12 PDUFA date. The proposed trade name is Luxturna.

Eye

Spark Therapeutics Inc. could bring the first gene therapy to the US market in 2018, after the company said it filed a biologic license application (BLA) for the drug has been accepted by the FDA for priority review with an action date of Jan. 12. The launch of a potential one-time treatment that could represent a cure for vision loss due to a certain inherited retinal disease (IRD) will pose new questions for the industry related to cost, reimbursement and the value of medicines.

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