Biosimilar Hulio Gets FDA Approval
The Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp; Mylan), a biosimilar to Humira® (adalimumab; AbbVie).
Musculoskeletal Disorders
Upadacitinib Beats Methotrexate in Early Rheumatoid Arthritis
Significantly better clinical, radiographic, patient-reported outcomes seen with upadacitinib.
Trends in Skeletal Muscle Relaxant Prescribing Examined
Office visits with prescribed SMR nearly doubled; tripling in visits for continued SMR drug therapy.
Casimersen NDA Submitted for Duchenne Muscular Dystrophy
Sarepta Therapeutics has completed the submission of the casimersen (SRP-4045) NDA for the treatment of Duchenne muscular dystrophy in patients who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.
Contraceptives Beneficial for Premature Ovarian Insufficiency
Combined oral contraceptives linked to improvement in bone mass, similar to that with high-dose HT.
Small Increase Seen in Risk for Subdeltoid Bursitis With Flu Shot
Attributable risk was 7.78 additional cases of subdeltoid bursitis per million persons vaccinated.
Implantable Neurostimulation Device Cleared for Chronic Low Back Pain
The FDA has approved ReActiv8® (Mainstay Medical), an implantable neurostimulation system, for the treatment of intractable chronic low back
Crysvita Approved for Treatment of Tumor-Induced Osteomalacia
The FDA as approved Crysvita® (burosumab-twza; Ultragenyx) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in patients aged ≥2 years.
Cosentyx Approved for Nonradiographic Axial Spondyloarthritis
The FDA has approved Cosentyx® (secukinumab; Novartis) for the treatment of adults with active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
First Treatment for Adult Onset Still Disease Gets FDA Approval
The FDA has approved Ilaris (canakinumab; Novartis) for the treatment of active Still disease, including adult-onset Still disease.
