The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s rilonacept, and Zai Lab’s sulbactam/durlobactam (SUL-DUR) are set to obtain priority review statuses. These designations highlight the significance of these therapies in addressing critical medical needs.
Vonicog Alfa: Vascular Hemophilia Treatment
Vonicog alfa is a recombinant von Willebrand factor (rVWF) containing complete VWF polymers and ultra-large polymers (ULMs) with a long half-life. It is designed as a replacement treatment for vascular hemophilia and is already approved in the US, Canada, UK, Switzerland, Australia, and Japan. The drug is filed for indications including on-demand treatment, bleeding event control, and perioperative bleeding management in adult patients with vascular hemophilia (18 years and above).
Rilonacept: Autoimmune Disease Therapy
Rilonacept is a recombinant dimer fusion protein approved in the US for treating pyrroline-related periodic syndrome (CAPS) and recurrent pericarditis. It was made available in Bo’ao in June 2022 for use in autoimmune diseases, including CAPS. The indication prioritized for review is CAPS in adults and adolescents aged 12 and above, encompassing familial cold autoimmune syndrome and Muckle-Wells syndrome.
SUL-DUR: Combination Therapy for Acinetobacter Infections
SUL-DUR is a combination therapy consisting of sulbactam (an intravenous β-Lactam antibiotic) and durlobactam (a new broad-spectrum intravenous infusion β-Lactamase inhibitor). Developed to treat infections caused by Acinetobacter baumannii, including carbapenem-resistant strains, SUL-DUR has previously obtained Qualified Infectious Disease Product (QIDP) qualification, fast-track status, and priority review status in the United States. Zai Lab secured exclusive rights to the drug in Asia and South Asia through a licensing deal with Entasis in 2018. The prioritized indication this time is infection caused by the Baumannii-Acinetobacter calcium acetate complex, including multidrug-resistant and carbapenem-resistant strains.
Future Outlook
With these priority review statuses, Takeda, Zhongmei Huadong Pharma, and Zai Lab are poised to accelerate the development and market availability of their respective therapies. These designations underscore the potential of Vonicog alfa, rilonacept, and SUL-DUR to address significant unmet needs in vascular hemophilia, autoimmune diseases, and antibiotic-resistant infections.-Fineline Info & Tech
