New global data analysis from Phesi shows the extent of the impact from the war in Ukraine on clinical development.
The U.S. health agency extended the review period for the expanded use of AbbVie Inc.’s psoriasis drug Skyrizi by three months, citing the need for more time to review additional data submitted by the company.
The U.S. Food and Drug Administration was reviewing the application for the use of Skyrizi in patients aged 16 years of age or older with moderate to severe Crohn’s disease, a type of inflammatory bowel disease.
AbbVie reported the company’s fourth-quarter 2021 and full-year financial results on Feb. 2, with worldwide net reviews up 7.4% to $14.89 billion for the quarter. Total revenues for 2021 were $56 billion. The company’s anchor product remains Humira, which will begin to lose exclusivity in 2023.
During the Digestive Disease Week meeting, AbbVie presented late-breaking data analyses that showed both doses of Skyrizi met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo in two Phase III studies. The Lancet published results from pivotal global Phase III clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating Rinvoq (upadacitinib) in adults and adolescents with mild to severe atopic dermatitis who were candidates for systemic treatment.
Roche Holding’s experimental drug etrolizumab did not fare well in late-stage clinical trials in treating people with moderate to severe ulcerative colitis, the Swiss drugmaker said.
Business updates for various pharma and life science companies around the globe.
Treatment with Stelara is resulting in positive outcomes for patients with Crohn’s disease, as Janssen Pharmaceutical said 79% of patients in a late-stage trial showed a clinical response to the medication and 67% were in clinical remission.
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 Janssen Pharmaceutical Companies of Johnson & Johnson announced new three-year data from the IM-UNITI study, which demonstrates the continued efficacy of Stelara (ustekinumab) in improving clinical remission rates and shows the drug to be generally well-tolerated in patients with Crohn’s disease.
AbbVie’s biologic therapy Humira for autoimmune diseases was the worldwide prescription-drug sales leader in 2015 for the fourth consecutive calendar term.
