Ka la 11 Mphalane 2024, Hympavzi (marstacimab-hncq), lesole la 'mele la motho le shebileng "tissue factor pathway inhibitor" le amohetse US. FDAtumello e le sethethefatsi se secha sa ho thibela ho tsoa mali ho batho ba nang le haemophilia A kapa haemophilia B.
Pejana, ka la 19 Loetse 2024, Hympavzi e ile ea fuoa tumello ea ho bapatsa ke European Medicine Agency (EMA) bakeng sa prophylaxis ea liketsahalo tsa mali ho bakuli ba nang le hemophilia e matla A kapa B.
Hemophilia A ke lefu la ho tsoa mali le futsitsoeng le bakoang ke khaello ea mali a clotting factor VIII ha haemophilia B e bakoa ke ho se lekane ha karolo ea IX ea ho koala mali. Maemo ana ka bobeli a phekoloa ka mokhoa o tloaelehileng ka ho nkela lintlha tse sieo tsa ho koala mali ka liente.
Hympavzi e thibela ho tsoa mali ka mokhoa o fapaneng. E shebana le protheine ea tlhaho ea anticoagulation e bitsoang "tissue factor pathway inhibitor" mme e fokotsa ts'ebetso ea eona ea anticoagulation ka tsela eo e eketsa bongata ba thrombin.
Setlhare se secha se fana ka khetho e ncha ea kalafo ho bakuli. Ena ke kalafo ea pele, e se nang mabaka le ea hang ka beke bakeng sa haemophilia B.
Tumello ea FDA ea Hympavzi e ipapisitse le liphetho tse khotsofatsang ho tsoa tekong ea kliniki ea phase 3 multicentre e lekotseng polokeho le katleho ea eona ho bacha le bankakarolo ba baholo ba lilemo tse 12 ho isa ho tse <75 ba nang le haemophilia e matla A kapa e matla ho isa ho e matla ea haemophilia B.
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mehloling
- Phatlalatso ea Litaba ea FDA - FDA E Amohela Kalafo e Ncha ea Hemophilia A kapa B. E ngotsoe ka la 11 Mphalane 2024. E fumaneha ho https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hemophilia-or-b
- EMA. Hympavzi - Marstacimab. E fumaneha ho https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi
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, a human monoclonal antibody targeting “tissue factor pathway inhibitor” received US FDA’s approval as a new drug for prevention of bleeding episodes in individuals with hemophilia A or hemophilia B. ){kind=link}