argenx, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, announced that the company has agreed to acquire a U.S. Food and Drug Administration (FDA) Priority Review Voucher (PRV) from Bayer Healthcare Pharmaceuticals, Inc for $98 million. A PRV entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application (BLA), which reduces the target review time and may potentially lead to an expedited approval.
argenx expects to redeem the PRV for a future marketing application for its FcRn antagonist efgartigimod. It will not be used for the BLA filing of intravenous efgartigimod in generalized myasthenia gravis, which is on track to be submitted in 2020.
“Efgartigimod has the potential to offer a new therapy option to patients with severe autoimmune diseases. We are currently advancing both an intravenous and subcutaneous formulation, which we believe will capture variability in patient preferences around dosing schedule and convenience, and will allow us to reach the most number of patients. Through this investment in a PRV, we’ll be able to seek expedited review of a future marketing application and build additional optionality into our development plans for efgartigimod,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
The closing of the acquisition of the PRV is subject to customary closing conditions, including clearance under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
Efgartigimod is an investigational antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels representing a logical potential therapeutic approach for several autoimmune diseases known to be driven by disease-causing IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness; pemphigus vulgaris (PV), a chronic disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic bruising and bleeding disease; and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disease leading to impaired motor function.
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit www.argenx.com.