Sanofi and Regeneron's dupilumab gets Breakthrough designation from FDA

The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major Sanofi (EURONEXT: SAN) and Regeneron’s (Nasdaq: REGN) dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) twho are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

Dupilumab is an investigational therapy blocking interleukin (IL)-4 and IL-13, two cytokines required for the Th2 immune response. The designation is based on previously announced positive results from Phase I and II clinical trials. Dupilumab was created using Regeneron's pioneering VelocImmune technology and is being co-developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyposis. A Phase III clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis is ongoing.

"Moderate to severe atopic dermatitis is a debilitating, life-altering disease with very limited treatment options. Many patients suffer for years with widespread inflamed skin, debilitating itch, sleep disturbances and other challenges," said Julie Block, chief executive of the National Eczema Association.

If approved, dupilumab would join a market set to reach $5.6 billion by 2022

Assuming its eventual regulatory approval in this indication, dupilumab will join a multi-billion dollar market. Atopic dermatitis therapeutic sales in nine major global markets are forecast to increase from $3.9 billion in 2012 to $5.6 billion by 2022, according to research and consulting firm GlobalData (The Pharma Letter November 15, 2013). The firm says the markets in the USA, France, Germany, Italy, Spain, UK, Japan, China and India will expand at a compound annual growth rate (CAGR) of 3.8%.