The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
Sanofi’s new Cambridge Crossing site/courtesy of Sanofi
Sanofi is on a roll this week with the U.S. Food and Drug Administration approval of Dupixent (dupilumab) for children aged 6 months to 5 years who are living with moderate-to-severe atopic dermatitis (AD), and the official launch of a massive new office.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat AD from infancy to adulthood. The company has also filed an application with the European Medicines Agency and regulators in other countries for small children.
“We’re pleased to see how scientific innovation and research continues to address unmet needs for the atopic dermatitis community, and we’re hopeful for the positive impact Dupixent can have for these children and their families,” commented Julie Block, president and chief executive officer of the National Eczema Association, in a statement.
Dupixent was granted Priority Review status for this indication by the FDA, which based its final decision on positive results from the Phase III trial which looked into the drug’s efficacy and safety when combined with low-potency topical corticosteroids (TCS) versus using TCS alone. Dupixent, which Sanofi and Regeneron jointly develop, achieved the primary endpoint for the 6 months to 5 years age group, with 28% achieving clear or almost clear skin compared to 4% in the group given a placebo. Improvements in overall disease severity logged 53% in the Dupixent plus TCS group compared to only 11% in the placebo group. All primary and secondary endpoints were met.
“Dupixent has changed the atopic dermatitis treatment paradigm – significantly clearing skin and reducing itch – by targeting an underlying cause of this disease without broadly suppressing the immune system. Today’s approval brings the proven efficacy and, importantly, well-established safety profile of Dupixent to these young children, making it the first of its kind to be approved for any U.S. patient aged six months or older living with this debilitating disease,” noted George Yancopoulos, M.D., Ph.D., president and CEO of Regeneron.
Cambridge Crossing Officially Opens
In other news, Sanofi announced the official opening of a new 900,000-square-foot campus at Cambridge Crossing in Cambridge, Massachusetts, with the goal to strengthen collaborative efforts between its medical, research and development and specialty care business units, among others. The Cambridge Crossing site houses two buildings that feature state-of-the-art technology, including CO2 sensors, automated light dimming and advancing cooling and heating systems. The move is part of Sanofi’s commitment to support and develop sustainable communities via its Play to Win program.
“We have built an unparalleled facility for our R&D community in Cambridge with a focus on ultra-modern laboratories in close proximity to our scientific and commercial colleagues,” Dr. John Reed, executive vice president and global head of R&D at Sanofi, said. “Located in the heart of an innovation ecosystem, our new site will serve as an open space to connect our experts with key partners, including top academic research institutions and hospitals, with the goal of urgently meeting patient needs through the tireless advance of science.”
