FDA Breakthrough Therapy Designation #56: Regeneron Pharmaceuticals And Atopic Dermatitis

Regeneron Pharmaceuticals and Sanofi announce on November 20^th that the FDA grants the coveted Breakthrough Therapy Designation (BTD) to investigational therapy, Dupilumab. The FDA BTD for Dupilumab is for the treatment of adults with moderate-to-severe Atopic Dermatitis (AD), who aren’t controlled adequately with topical prescription therapy and/or for whom these treatments aren’t appropriate. The BTD is based on positive results from Phase I and II clinical trials. A global Phase III clinical program for Dupilumab is ongoing.

Moderate-to-severe AD is a serious form of eczema that is a chronic inflammatory disease. AD in patients results in pruritus, cutaneous dryness, and skin lesions marked by redness, crusting/oozing, and other symptoms.

Regeneron Pharmaceuticals, a Tarrytown, New York-based biotech company, has 3 approved products that the company sells through collaborations with other large pharmaceutical companies. This is the 2^nd FDA BTD for Regeneron Pharmaceuticals:

#	Drug Name	Sponsor Company	Indication
1	Eylea (Aflibercept)	Regeneron Pharmaceuticals	Diabetic Retinopathy in Patients with Diabetic Macular Edema
2	Dupilumab	Regeneron Pharmaceuticals/ Sanofi	Atopic Dermatitis

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Regeneron Pharmaceuticals was in the news during the summer, when BioMarin Pharmaceutical sold its Rare Pediatric Disease Priority Review Voucher  for $67.5 million to the company and Sanofi.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

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