The Latest: FDA advisers endorse gene therapy for blindnessOctober 12, 2017 7:33pm

SILVER SPRING, Md. (AP) — The Latest on an FDA panel's discussion on a gene therapy treatment for blindness (all times local):

3:19 p.m.

U.S. health advisers have endorsed an experimental approach to treating inherited blindness, setting the stage for the likely approval of an innovative new genetic medicine.

A panel of experts to the Food and Drug Administration voted unanimously in favor of Spark Therapeutics' injectable therapy, which aims to improve vision in patients with a rare mutation that gradually destroys normal vision. The vote amounts to a recommendation to approve the therapy.

The FDA has until mid-January to make its decision. The agency does not have to follow the panel's recommendation, though it often does.

If approved, the treatment called Luxturna would be the first gene therapy in the U.S. for an inherited disease, offering hope to patients with a variety of genetic disorders.

___

8:30 a.m.

U.S. health advisers are reviewing a novel treatment for a rare form of inherited blindness, potentially setting the stage for the launch of a groundbreaking new genetic medicine.

The Food and Drug Administration panel will vote Thursday on whether to recommend approval of Philadelphia-based Spark Therapeutics' treatment, which aims to improve vision in some patients with hereditary blindness by replacing a defective gene that affects vision.

The FDA is not required to follow the group's recommendation, but such deliberations are generally the final step in the agency's decision-making process. The FDA has until mid-January to decide. If approved, it would be the first gene therapy in the U.S. for an inherited disease, offering hope to patients with a variety of related conditions.

Page 1 of 1

More Stories Like This

FILE - In this July 24, 2017, file photo, President Donald Trump speaks about healthcare in the Blue Room of the White House in Washington. The top lawyers for 19 states will urge a federal judge Monday, Oct. 23, 2017, to force Trump's administration to pay health care subsidies he abruptly cut off earlier this month. State attorneys general, led by California Democrat Xavier Becerra, argue the monthly payments are required under former President Barack Obama's health care law, and cutting them off will harm consumers. (AP Photo/Alex Brandon, File)
Judge: Trump's health care cuts don't pose immediate threat
California company recalls vegetables over listeria fearsA California company has voluntarily recalled packaged vegetables distributed throughout the U.S. and Canada because of possible bacterial contamination
Gaza to get second cellular network, from QatarA Palestinian cellular provider says it will soon expand coverage from the West Bank to the Gaza Strip
Business HighlightsBusiness Highlights
This Wednesday, May 3, 2017, photo shows a Target store in Omaha, Neb. Target says customers want it to pause the "Christmas creep." The retailer says it wants to be more in tune with customers' mindset, so it plans to ease in holiday promotions this year while better recognizing Thanksgiving. (AP Photo/Nati Harnik)
Target says customers want it to pause the 'Christmas creep'
Kia recalls Souls in US for second timeKia recalls 342,381 Souls for a second time in US because of steering defect
This component is currently unavailable.
AdChoices

Related Searches

Related Searches

AdChoices