Rinvoq Approved for Active Ankylosing Spondylitis
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
The approval was based on data from a phase 3 study that included 175 adults with generalized myasthenia gravis who were not previously treated with a complement inhibitor.
Orphenadrine citrate ER tablet is indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
A EULAR task force recently developed recommendations for the management of cardiovascular risk in patients with rheumatic and musculoskeletal diseases, including gout, lupus, and systemic sclerosis.
The sBLA submission is supported by data from the phase 4 MIRROR trial.
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
Risdiplam is a survival motor neuron 2 splicing modifier.
The approval was based on data from 2 pivotal phase 3 studies, which compared Skyrizi to placebo in adults with active PsA who had an inadequate response or were intolerant to biologic therapy and/or nonbiologic DMARDs.
The sBLA submission is supported by data from the phase 4 MIRROR trial.
The Company is currently evaluating DYN101 in the phase 1/2 UNITE-CNM trial in patients 16 years of age and older with CNM caused by mutations in the MTM1 or DNM2 gene.