Drugs in the Pipeline, News
The FDA's Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
Drugs in the Pipeline, News
Rilzabrutinib is an oral Bruton tyrosine kinase inhibitor currently in development for a number of immune-mediated diseases.
Drugs in the Pipeline
The BLA submission is supported by data from the PATHFINDER clinical program.
Drugs in the Pipeline
The submission was based on data from the double-blind, placebo-controlled VOYAGE trial.
Drugs in the Pipeline
Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin.
Drugs in the Pipeline
Findings from a phase 3b trial showed that a majority of patients with severe eosinophilic asthma treated with benralizumab (Fasenra; AstraZeneca), an interleukin-5 antagonist, were able to eliminate or reduce oral corticosteroid (OCS) use. The open-label, single-arm PONENTE trial assessed the efficacy and safety of reducing OCS use after initiating treatment with benralizumab in nearly…
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.
Drugs in the Pipeline
Updated on 6/16 While no specific treatment for coronavirus disease 2019 (COVID-19) is currently available, several therapies are being investigated globally.* AB201 (ARCA biopharma): a selective inhibitor of tissue factor being developed as a potential treatment for COVID associated coagulopathy. Clinical testing is expected to begin in the second half of 2020. Acalabrutinib (AstraZeneca): a…
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).