AbbVie Remains Confident About Rinvoq Despite Coming Safety Labeling Update
A safety-related FDA revision of Rinvoq’s label in rheumatoid arthritis is a perceived threat to the JAK inhibitor’s growth, but it and fellow immunology asset Skyrizi produced another strong sales quarter.
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AbbVie had no presence in ophthalmic medicine other than a single indication for Humira before the Allergan merger, but now has a growing eye care portfolio, including early FDA approval of Vuity for presbyopia.
The US FDA approved the oral CGRP inhibitor Qulipta (atogepant) for migraine prevention, making AbbVie the only company with three drugs for three different migraine indications.
US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks
Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.