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FDA approves first gene therapy ointment

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Biotech companies are getting creative with how they deliver DNA fixes into people’s bodies.  Last Friday, the US Food and Drug Administration (“FDA”) approved sales of the first gene therapy that is an ointment directly applied to the body – as well as the first intended to be used on the same person repeatedly.


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The gene therapy treatment, called Vyjuvek, was developed by the Pittsburgh startup Krystal Biotech and is approved for treating anyone older than six months of age with this specific form of epidermolysis bullosa.  It introduces a missing gene to skin cells so they can make collagen. It’s already helping people with dystrophic epidermolysis bullosa, a rare inherited disease that makes skin incredibly fragile. The topical ointment helps to heal the disease’s chronic, blistering wounds, while an eyedrop version can prevent scar tissue from building up in their eyeballs and improve their vision.

The gene treatment is unusual as it doesn’t involve injection or altering immune cells outside the body. Gene delivery usually involves placing a DNA strand inside a virus naturally equipped to enter a human cell and drop off the gene. In Krystal’s case, the company is using herpes simplex virus, the same one that causes cold sores. HSV-1, as the virus is known, is very common which means it is fairly safe, but it also has the advantage that it naturally evades the immune system.

Since 2017, the FDA has approved five gene therapies for rare inherited diseases – Krystal’s will make it six – and several others for treating blood cancer. But those earlier treatments are all delivered by injection or by altering immune cells outside the body. By formulating gene therapy into an ointment that’s rubbed on, Krystal has achieved what its CEO, Krish Krishnan, has called “a simple, convenient, patient-friendly way to provide the missing gene to these patients.”

The novel delivery strategy is already being studied to treat other rare skin conditions. An inhaled gene therapy to treat cystic fibrosis is also being explored. Krystal has already demonstrated the versatility of its approach by developing an eye-drop version of Vyjuvek at the request of an ophthalmologist. 

Gene replacement for skin may also have lucrative future uses in cosmetics. A subsidiary established by Krystal has begun testing a version of Vyjuvek on volunteers to try to reverse crow’s feet and other wrinkles caused when people’s bodies make less collagen as they age.

Krystal Biotech is among dozens of companies seeking innovative ways to deliver replacement genes to more locations in the human body, including hard-to-reach organs like the brain.

Read the full article ‘The FDA just approved rub-on gene therapy that helps “butterfly” children’  published by MIT Technology Review HERE.

Featured image: Krystal Biotech on Twitter

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Phyllis Cline
Phyllis Cline
3 months ago

Hello America

Augustus
Augustus
Reply to  Phyllis Cline
3 months ago

Hello

Augustus
Augustus
3 months ago

The FDA has no credibility. Trusting in them is equivalent to trusting a rattlesnake.

Kay W
Kay W
Reply to  Augustus
3 months ago

I’ve dealt with a good number of rattlesnakes. They are far more trustworthy than the FDA.

Augustus
Augustus
Reply to  Kay W
3 months ago

Me too. South Texas has its share.

trackback
3 months ago

[…] Go to Source Follow altnews.org on Telegram […]

biggrump
biggrump
3 months ago

Fairly safe? The jab is supposedly safe and effective and we know how true that is. It suggests that if you use this ointment, you better get your affairs in order.

Gravity 2
Gravity 2
3 months ago

This new product should also be called ‘damage control’ to show that there are some non-invasive mRNA gene editing applications that don’t cause myocarditis, trigger spike protein auto-immune problems and inflammation.

trackback
3 months ago

[…] – FDA approves first gene therapy ointment […]

trackback
3 months ago

[…] FDA approves first gene therapy ointment Biotech companies are getting creative with how they deliver DNA fixes into people’s bodies.  Last Friday, the US Food and Drug Administration (“FDA”) approved sales of the first gene therapy that is an ointment directly applied to the body – as well as the first intended to be used on the same person repeatedly. […]

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3 months ago

[…] Read More: FDA approves first gene therapy ointment […]

john
john
3 months ago

make straight the paths for the lord you sidewinding slithering snakes,
gaze upon the truth about about who you are— lifting up the snake
know what you have done— lifting up the cross