The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who have had poor responses to other systemic therapies, and patients aged 18 and above with complex urinary tract infections (cUTI) caused by bacteria sensitive to cefepime-taniborbactam, including pyelonephritis.
Details of the Priority Reviewed Drugs
Abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, is used to treat adult patients with refractory, moderate to severe AD who have had poor responses to other systemic therapies or are not suitable for these treatments. Currently, only AbbVie’s (NYSE: ABBV) JAK1 inhibitor Rinvoq (upadacitinib) has been approved to treat AD in China, making abrocitinib a potentially important alternative.
Cefepime-taniborbactam is an investigational intravenous (IV) beta-lactam/beta-lactamase inhibitor antibiotic developed by Venatorx Pharmaceuticals for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. Everest Medicines, under an exclusive licensing agreement with Venatorx Pharmaceuticals, holds the rights to develop and commercialize cefepime-taniborbactam in Greater China, South Korea, and select southeast Asian countries.
Implications of Priority Reviews
The priority review status granted by the CDE underscores the urgency and unmet medical need for effective treatments in these areas. It is expected to expedite the regulatory process, potentially making these therapies available to patients more quickly and improving clinical outcomes.-Fineline Info & Tech
