Biosimilar Hulio Gets FDA Approval
The Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp; Mylan), a biosimilar to Humira® (adalimumab; AbbVie).
Psoriasis
Imsidolimab Gets Orphan Drug Designation for Generalized Pustular Psoriasis
Generalized pustular psoriasis is a rare systemic inflammatory disease characterized by inflamed skin and small pustules.
Superior Skin Clearance Observed With Risankizumab in Head-to-Head Psoriasis Study
New data from a head-to-head study comparing risankizumab-rzaa to secukinumab in patients with moderate to severe plaque psoriasis were recently presented online at the American Academy of Dermatology virtual annual meeting.
Significant Improvements Observed With Apremilast in Mild to Moderate Plaque Psoriasis
Amgen announced positive topline results from the phase 3 study of apremilast (Otezla®), a phosphodiesterase 4 (PDE4) inhibitor, for the treatment of adults with mild to moderate plaque psoriasis.
Scalp Psoriasis Study Data Added to Otezla Labeling
The labeling for Otezla (apremilast; Amgen) has been updated to include safety and efficacy information related to the treatment of patients with moderate to severe plaque psoriasis of the scalp. The STYLE trial was a double-blind, placebo-controlled study that included 303 patients with moderate to severe plaque psoriasis of the scalp who had a Scalp…
Taltz Approved for Pediatric Patients with Moderate to Severe Plaque Psoriasis
The FDA has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Certain Blister Packages of Sandimmune, Neoral Not Child Resistant
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…
Comparative Efficacy of Systemic Psoriasis Treatments Evaluated
Among systemic treatments for plaque psoriasis, brodalumab, guselkumab, ixekizumab, and risankizumab-rzaa were found to be associated with the highest Psoriasis Area and Severity Index (PASI) response rates.
Risankizumab Superior to Secukinumab in Plaque Psoriasis Trial
AbbVie announced positive topline data from a phase 3 study evaluating the efficacy and safety of risankizumab (Skyrizi) compared with secukinumab (Cosentyx; Novartis) in adult patients with moderate to severe plaque psoriasis.
23andMe Develops Drug Compound Using Consumer Genetic Data
23andMe, a consumer genetics company, has licensed its first drug compound to Almirall, a global pharmaceutical company.
