Sanofi and Regeneron Pharmaceuticals Inc.'s novel therapy Dupixent (dupilumab) has hit both primary endpoints in a Phase III trial in asthma, showing a greater benefit in those most allergic form of the disease and setting the stage for a US FDA filing to expand its indications by the end of the year.
The product – which was approved in March by the FDA for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapy or when therapies are not advisable – has been tipped as a potential blockbuster and its early market performance is being closely watched