Spark Therapeutics' blindness gene therapy Luxturna backed by FDA panel

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Spark Therapeutics' blindness gene therapy Luxturna backed by FDA panel

- firstwordpharma.com
13 Oct 2017
An FDA advisory panel on Thursday voted unanimously in favour of supporting approval for Spark Therapeutics' experimental gene therapy Luxturna (voretigene neparvovec), which is designed to treat patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease. Jefferies analyst Michael Yee has said approval of the therapy would "thematically ...

Spark's Gene Therapy to Restore Vision Wins Unanimous FDA Panel Vote

13 Oct 2017
If the FDA approves the Spark drug, voretigene neparvovec (Luxturna), it would mark the first therapy approved by the agency that replaces a faulty gene with a working one, offering a long-lasting treatment, and perhaps even a cure. Though the panel's vote is advisory, FDA staff do consider the discussion and recommendation of these committees. An FDA decision is expected ...
- xconomy.com

First Gene Therapy For An Inherited Disorder Gets Expert Endorsement Health

- npr.org
13 Oct 2017
First Gene Therapy For An Inherited Disorder Gets Expert Endorsement : Shots - Health News After many setbacks for genetic therapies, advisers to the Food and Drug Administration recommended approval of the first gene treatment for an inherited form of blindness.

FDA advisers endorse gene therapy to treat form of blindness

13 Oct 2017
Dr. Barry Byrne listens to testimony concerning the approval of a potentially breakthrough drug for a form of blindness during a meeting of the The Cellular, Tissue and Gene Therapies advisory committee, Thursday, Oct. 12. 2017, at the FDA in Silver Spring, Md. (AP Photo/Nick Wass)
- abcnews.go.com

After a unanimous panel vote, will Spark's novel gene therapy be a 1 million drug

- statnews.com
13 Oct 2017
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.

FDA advisers endorse gene therapy to treat form of blindness

13 Oct 2017
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.
- cbsnews.com

The First Gene Therapy That Fixes Hereditary Blindness May Finally Get FDA Approval

- mo.bi
13 Oct 2017
We've already seen projects that use gene therapy to tackle everything from brain diseases to broken bones . However, these treatments will all require FDA approval -- so scientists working in this sphere will likely be watching today's decision regarding Luxturna very closely.
#DrugAdministration      #SparkTherapeuticsInc      #UsFood     
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