Risdiplam Gets Prority Review for Presymptomatic Spinal Muscular Atrophy
Risdiplam is a survival motor neuron 2 splicing modifier.
Musculoskeletal Disorders
Skyrizi Gets FDA Approval for Psoriatic Arthritis
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.
Bimekizumab Meets All Endpoints in Psoriatic Arthritis Trial
The phase 3 BE COMPLETE study included 400 adults with active psoriatic arthritis who were inadequate responders or intolerant to anti-TNF-α therapy.
Study Supports Bimekizumab for Nonradiographic Axial Spondyloarthritis
The ongoing phase 3 BE MOBILE 1 study compared the efficacy and safety of bimekizumab to placebo in adults with active nr-axSpA.
Hip Fracture Risk Up With Drug Holiday From Risedronate vs Alendronate
After 3 or more years of therapy, drug holidays from risedronate versus alendronate linked to 18% increase in hip fracture risk
New Drugs Approved in 2021
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Horizon Seeks Approval of Pegloticase Plus Methotrexate for Uncontrolled Gout
The sBLA submission is supported by data from the phase 4 MIRROR trial.
Antisense Oligonucleotide Fast Tracked for Myotubular and Centronuclear Myopathies
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.
Duloxetine Does Not Alleviate Pain in Chronic Osteoarthritis
No differences seen in WOMAC pain at three or 12 months with duloxetine added to usual care, or in subgroup with symptoms of centralized pain
Cosentyx Approved for Enthesitis-Related Arthritis, Juvenile Psoriatic Arthritis
The approval was based on data from the 2-year phase 3 JUNIPERA study that evaluated secukinumab in pediatric patients aged 2 to 17 years with a confirmed diagnosis of ERA or JPsA.
