The FDA has recently granted the Fast Track designation to AGLE-102, a treatment for dystrophic epidermolysis bullosa. This designation will allow for the treatment to reach patients at a quicker pace.
About Dystrophic Epidermolysis Bullosa
Dystrophic epidermolysis bullosa (DEB) is one of the forms of epidermolysis bullosa, characterized by fragile skin that blisters easily. Minor friction causes these blisters, which typically appear on the hands, elbows, knees, and feet, although all parts of the body can be affected. In fact, severe cases see the eyes blisters, causing vision loss. Scarring and other serious medical problems can arise from this condition as well. This condition is genetic, and it can be inherited in an autosomal recessive or dominant pattern. Regardless of inheritance, the COL7A1 gene is mutated in affected individuals.
Fast Track Designation for AGLE-102
The Fast Track designation is reserved for drugs that treat a serious condition with an unmet medical need. It leads to faster development, as the creator of the medication will have more access to the FDA and a quicker review and approval process.
AGLE-102, the drug that received this designation, is an extracellular vesicle therapy. It is intended to deliver proteins, healing factors, and genetic material to the damaged and blistered tissue that is common in dystrophic epidermolysis bullosa. Starting in 2021, it will be evaluated in a Phase 1/2a trial. Hopefully the development of this drug is successful, as it would better the lives of many patients with DEB.
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