Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced detailed positive results from a late-stage study evaluating asthma drug, Dupixent.
The phase III study results evaluating Dupixent in children aged 6-11 years with uncontrolled severe atopic dermatitis showed that the drug when combined with standard-of-care topical corticosteroids (TCS) significantly improved disease signs, symptoms and health-related quality of life in these children.
At 16 weeks, approximately three times as many children who were treated with Dupixent and TCS achieved clear or almost clear skin. More than two-thirds experienced at least a 75% overall improvement compared to TCS alone. In addition, more than three times as many children experienced a significant reduction in itch with Dupixent and TCS compared to TCS alone.
The data further reinforces consistent safety and tolerability profile observed across adult and adolescent atopic dermatitis patients, which also includes a numerically lower rate of skin infections compared to placebo.
We note that the supplemental BLA for the drug in this indication is currently under Priority Review with a target action date of May 26, 2020.
Per Regeneron, there are currently no biologic medicines approved for children with severe atopic dermatitis.
Dupixent is one of the key drugs for Regeneron and a label expansion will further boost sales of this drug, which has performed impressively last year.
Dupixent is already approved in the United States for moderate-to-severe atopic dermatitis, for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in combination with other medicines, and with other medicines to treat chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled.
Both companies are also evaluating Dupixent in a broad program of diseases driven by allergic and other type 2 inflammation, including pediatric asthma, pediatric atopic dermatitis, eosinophilic esophagitis and chronic obstructive pulmonary disease, among others.
Regeneron has been in the news lately owing to its efforts to develop treatments for COVID-19. The company has identified antibodies, which can possibly treat COVID-19. It has now isolated hundreds of virus-neutralizing, fully-human antibodies from its VelocImmune mice, which have been genetically-modified to have a human immune system. The company has also isolated antibodies from humans who have recovered from COVID-19 to maximize the pool of potent antibodies. The company plans to select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein as well as other desirable qualities.
Regeneron’s shares have lost 10.2% in the year so far compared with the industry’s decline of 10.6%.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.
Regeneron and Sanofi are also evaluating their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19.
The pandemic has put the spotlight on the biotech sector, which is striving hard to come out with effective treatments for the contagion at the earliest. Biotech giant Amgen (AMGN - Free Report) is the latest company to join the bandwagon. It recently collaborated with Adaptive Biotechnologies to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.
Gilead Sciences, Inc. (GILD - Free Report) is currently working to evaluate the safety and efficacy of the experimental Ebola treatment, remdesivir, as a potential treatment for COVID-19 in multiple ongoing studies.
Regeneron currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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