Drugs in the Pipeline
The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
News
The FDA has expanded the approval of Dupixent® (dupilumab; Regeneron and Sanofi) to include patients aged 6 to 11 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
News
Recommendations on the management of coronavirus disease 2019 (COVID-19) were recently released by the National Institutes of Health (NIH) to help guide clinicians caring for patients with COVID-19.
News
The American College of Allergy, Asthma and Immunology (ACAAI) has issued a statement regarding the use of corticosteroids for patients with allergies and asthma.
Safety Alerts and Recalls
Certain blister packages of Sandimmune (cyclosporine capsules) and Neoral (cyclosporine capsules) may not meet child-resistant packaging requirements, according to manufacturer Novartis. The Company announced that it is working with the Consumer Product Safety Commission to address the packaging issue. In a press statement, Novartis stressed that there are no quality or efficacy issues with the…
Dermatological Disorders, Drugs in the Pipeline
Dupixent, an interleukin-4 receptor alpha antagonist, is currently approved for moderate to severe atopic dermatitis in patients ≥12 years old who are not adequately controlled with topical prescription therapies or when they are not advisable.
Drugs in the Pipeline
Results showed that the 4mg dose of baricitinib plus TCS met the primary end point, with 31.5% of patients achieving EASI75 compared with 17.2% of patients in the placebo plus TCS group (P ≤.05).
Drugs in the Pipeline
Treatment with masitinib, a selective tyrosine kinase inhibitor, significantly reduces the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by oral corticosteroids, according to data from a phase 3 study.
News
Rituximab was found to be superior to mycophenolate mofetil (MMF) in adult patients with severe pemphigus vulgaris, according to new phase 3 trial data.
Drugs in the Pipeline
Adding baricitinib to topical corticosteroids significantly improved disease severity in adult patients with moderate to severe atopic dermatitis, according to top-line results from BREEZE-AD7 study. The phase 3 study included 300 patients who had been diagnosed with moderate to severe atopic dermatitis for at least 12 months and had an inadequate response to topical medications.…
