Regeneron, ReGen Therapeutics Plc Eczema Drug Dupilumab Gets FDA Breakthrough Therapy Designation
November 20, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to the companies’ eczema drug dupilumab. The designation was based on positive results from Phase 1 and 2 trials of dupilumab, a fully-human monoclonal antibody directed against the shared IL-4 receptor alpha subunit, which blocks signaling from key cytokines required for the initiation and maintenance of the immune response.
“Moderate-to-severe atopic dermatitis [also referred to as eczema] is a debilitating, life-altering disease with very limited treatment options,” said Chief Executive Officer of the National Eczema Association Julie Block in a statement. “Many patients suffer for years with widespread inflamed skin, intense itch, sleep disturbances and other challenges. We are thrilled to see the FDA recognizing the need to expedite and prioritize potential new options for these patients.”
Sanofi and Regeneron have high hopes for the drug, which could be a potential blockbuster if it is shown to be an effective treatment of asthma and chronic sinusitis with nasal polyps, reported Reuters.
The Pharma Letter reported that according to the research and consulting firm GlobalData, sales of eczema treatments are forecast to increase from $3.9 billion in 2012 to $5.6 billion by 2022. The firm also projects that the markets in the USA, France, Germany, Italy, Spain, UK, Japan, China and India are forecast to expand at a compound annual growth rate (CAGR) of 3.8 percent.
Moderate-to-severe atopic dermatitis, a serious form of eczema, is a chronic inflammatory disease characterized by an allergic response. People suffering from eczema experience severe itching, skin lesions marked by redness, crusting and oozing, as well as skin thickening. Because of the scratching trigged by the itches, skin damage can lead to secondary infections. Sanofi and Regeneron cited several research studies in their press release that demonstrate the cost of eczema to society in the form of medical care, prescription drugs and loss of productivity due to job avoidance.
The FDA designed the Breakthrough Therapy designation to expedite treatment to patients for conditions that are serious or life threatening when “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,” according to the FDA’s website. The designation includes all the Fast Track program features, as well as more intensive FDA guidance and discussion throughout the drug research process.