Regeneron and Sanofi Announce that Dupilumab Has Received FDA Breakthrough Therapy Designation in Atopic Dermatitis
Regeneron Pharmaceuticals and Sanofi have announced that the FDA has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response. The designation is based on positive results from Phase I and II clinical trials.
"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, intense itch, sleep disturbances and other challenges," said Julie Block, CEO, National Eczema Association. "We are thrilled to see the FDA recognising the need to expedite and prioritise potential new options for these patients."
Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy. The designation includes all of the Fast Track programme features, as well as more intensive FDA guidance and discussion. The Breakthrough Therapy designation is distinct from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.
A Phase III worldwide clinical programme for dupilumab in adults with moderate-to-severe atopic dermatitis is ongoing.
Related News
-
News A Day in the Life of a Start-Up Founder and CEO
At CPHI we work to support Start-Up companies in the pharmaceutical industry and recognise the expertise and innovative angles they bring to the field. Through our Start-Up Programme we have gotten to know some of these leaders, and in this Day in the ... -
News Biopharmaceutical manufacturing boost part of new UK government budget
In their national budget announced by the UK Labour Party, biopharmaceutical production and manufacturing are set to receive a significant boost in capital grants through the Life Sciences Innovative Manufacturing Fund (LSIMF). -
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. -
News CPHI Podcast Series: Why we need to consider women in clinical trials
The latest episode of the CPHI Podcast Series with Lucy Chard covers women's health, specifically women's representation in clinical trials, the associated bias, and the impacts on health for this population. -
News US FDA does not approve MDMA therapy for PTSD, requests more data
The MDMA-based therapeutic developed by Lykos Therapeutics, a California-based Public Benefit Corporation (PBC), has been reviewed and unapproved by the US FDA. The regulator has requested additional phase III trial data for further safety and efficacy... -
News Novartis and Viatris latest facing lawsuit over HeLa cell misuse
Global pharmaceutical companies Novartis and Viatris are the latest hit with a lawsuit claim pertaining to alleged misuse of the ‘HeLa’ cell line from the estate of woman whose cancerous tissue cells were taken without consent. -
News Sanofi invests billions into Frankfurt insulin production site
French pharmaceutical company Sanofi have announced an investment of EUR1.3 billion at their existing BioCampus site in Frankfurt am Main for the expansion of insulin production.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance