The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
The U.S. FDA approved AbbVie Inc.’s Skyrizi as a treatment for plaque psoriasis at a time when the company’s blockbuster psoriasis medicine Humira faces patent pressures.
Eli Lilly and Company announced today the initiation of the IXORA-R head-to-head clinical trial, designed to evaluate superiority between Taltz (ixekizumab) and Tremfya (guselkumab) in adult patients with moderate-to-severe plaque psoriasis.
Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
Encouraging results were reported from UNVEIL, the first trial of patients with moderate plaque psoriasis who were naïve to systemic and biologic therapy.
AbbVie’s biologic therapy Humira for autoimmune diseases was the worldwide prescription-drug sales leader in 2015 for the fourth consecutive calendar term.
The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.