{
  "id": 7405548,
  "title": "SFDA becomes first global regulator to approve Frehemgo for Hemophilia A bleeding prevention",
  "url": "https://urgent.news/2026/09/14/sfda-becomes-first-global-regulator-to-approve-frehemgo-for",
  "topic": "world",
  "section": "World",
  "published": "2026-09-14T20:39:32.000Z",
  "source": {
    "name": "Saudi Gazette",
    "slug": "saudi-gazette",
    "url": "https://saudigazette.com.sa/article/664573/saudi-arabia/sfda-becomes-first-global-regulator-to-approve-frehemgo-for-hemophilia-a-bleeding-prevention"
  },
  "original_language": "en",
  "account": "The Saudi Food and Drug Authority (SFDA) has made history by becoming the first regulatory body globally to approve Frehemgo (denecimig) for preventing bleeding episodes in patients with hemophilia A, including those with factor VIII (FVIII) inhibitors. Hemophilia A is a genetic disorder where the body lacks sufficient FVIII, leading to frequent bleeding issues. Prior to its green light, Frehemgo was under the SFDA’s Breakthrough Medicine Program, aimed at speeding up access to crucial treatments in Saudi Arabia.\n\nFrehemgo is a unique bispecific antibody that functions like activated FVIII, linking coagulation factors IXa (FIXa) and factor X (FX) on platelets’ surface. This action kickstarts thrombin production and strengthens the clotting process, thereby preventing bleeding regardless of FVIII inhibitor presence. The drug is introduced through subcutaneous injection, with frequency depending on the patient’s weight and the doctor’s judgment – weekly, biweekly, or monthly.\n\nThe SFDA’s approval came after a thorough examination of Frehemgo’s efficacy, safety, and quality, all grounded in the data from its registration dossier. The drug’s effectiveness and safety were tested in four Phase 3 studies involving patients across various severities of hemophilia A, including adults, adolescents, pediatric patients, and an open-label extension study that covered all age groups. It was also assessed in a separate safety-only study to see how patients responded to switching from emicizumab.\n\nAlthough Frehemgo showed promising results, common side effects included injection site reactions like redness and itching, along with fever, headaches, and upper respiratory tract infections. Laboratory markers indicating active coagulation, such as prothrombin fragment 1+2 and D-dimer levels, were also found to be higher.",
  "summary": "RIYADH — The Saudi Food and Drug Authority (SFDA) has become the first regulatory body globally to approve the registration of Frehemgo (denecimig) for the routine prophylaxis of bleeding episodes in patients with hemophilia A, with or without factor VIII (FVIII) inhibitors. Hemophilia A is an inherited bleeding disorder caused by a deficiency or absence of FVIII, a protein essential for normal…",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}