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

November 23, 2014

Regeneron Pharmaceuticals and Sanofi announce on November 20th 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 2nd 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


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.



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Flickr – Nicholas T – Bows” by Nicholas A. Tonelli from Pennsylvania, USA (Bows) [CC-BY-2.0] | Wikimedia Commons.

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