Health
Novo Nordisk submits Biologics License Application (BLA) to FDA for Mim8; an investigational, prophylaxis treatment for people living with hemophilia A with or without inhibitors
Today, Novo Nordisk announced Mim8 (denecimig) has been submitted for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA), a formal request to evaluate a biologic medicine. Denecimig is an investigational, next-generation bispecific antibody Factor VIIIa (FVIIIa) mimetic, designed as a preventive bleed routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital FVIIIa defic
About this update from Novo Nordisk A/s Class B
[{"type":"list","items":[{"val":[{"type":"text","content":"If approved, Mim8 (denecimig) would offer the flexibility of treatment with a single-use, prefilled disposable pen injector with dosing options including once every month, once every two weeks, and once every week for people living with hemophilia A","length":249,"tagName":"p"}]},{"val":[{"type":"text","content":"In hemophilia A, denecimig is designed to help the body form blood clots more effectively and was studied as part of the FRONTIER program across different dosing frequencies, age groups, severities, and with or without inhibitors1","length":230,"tagName":"p"}]},{"val":[{"type":"text","content":"Novo Nordisk is advancing its long-standing commitment to people living with hemophilia A, a potentially life-threatening condition","length":131,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":610,"olType":false},{"type":"text","content":"BAGSVÆRD, Denmark and PLAINSBORO, N.J., Sept. 29, 2025 /PRNewswire/ -- Today, Novo Nordisk announced Mim8 (denecimig) has been submitted for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA), a formal request to evaluate a biologic medicine. Denecimig is an investigational, next-generation bispecific antibody Factor VIIIa (FVIIIa) mimetic, designed as a preventive bleed routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital FVIIIa deficiency), with or without inhibitors.2 If approved, denecimig will be the first FVIIIa mimetic with flexible once every month, once every two weeks, and once every week dosing in a pre-filled, single-use pen, catering to the diverse needs of people living with hemophilia A, with or without inhibitors.1","length":877,"tagName":"p"},{"type":"image","alt":"Novo Logo (PRNewsfoto/Novo Nordisk)","displaySize":"","headline":null,"caption":"Novo Logo (PRNewsfoto/Novo Nordisk)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":284,"url":"https://media.zenfs.com/en/prnewswire.com/4b2f344794d2390acbb0680ef27be374"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/IziRVJvc7vJZytJZg4CNLg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTUwMTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/4b2f344794d2390acbb0680ef27be374","width":400,"height":284},"resize_sm":{"url":"https...