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.

Unlock this article by subscribing to STAT Plus. To get you started, enjoy 50% off your first 3 months!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Buenas tardes, quisiera que por favor me ayudaran tengo una sobrina de 38 anos , es sordomuda y tiene sindrome de Usher, retinitis pigmentosa, ha perdido la vision de los lados , este tratamiento pudiera ayudarle a ella, por favor me indican el costo es una persona de muy bajos recursos, se deprime mucho por esta condicion y no se como ayudarla. Gracias por ayudarnos Dios les de mucha sabiduria para que continuen en tan excelente labor.

Your daily dose of news in health and medicine

Privacy Policy