Bayer Pharmaceutical Gets CDSCO Panel Nod To Import And Market Octocog alfa for hemophilia A
New Delhi: Granting the phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to Bayer Pharmaceutical to import and market Antihemophilic Factor (Recombinant Factor VIII) Lyophilized Powder for Solution for Intravenous Injection (Octocog alfa) indicated for use in adults and children with hemophilia A.
However, this approval is subject to the condition that the firm should conduct the Phase IV study. In addition, the committee recommended that the firm submit the Phase IV study protocol within three months of approval of the product.
This came after Bayer Pharmaceutical presented the safety and efficacy data from the clinical studies conducted globally along with subset analysis of subjects who participated from Asian countries and safety data in comparison with other Factor VIII drugs used in the centers where HFI donated the drug for a grant of permission to import and market the drug Antihemophilic Factor (Recombinant Factor VIII) 250, 500, 1000, 2000 and 3000 IU Lyophilized Powder for Solution for Intravenous Injection (Octocog alfa), indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes
The committee noted that the drug is approved in 67 countries, including the USA, the EU, Japan, and Canada.
The drug falls under the category of orphan drug and is indicated for the treatment of rare diseases.
The drug falls under the category of orphan drug and is indicated for the treatment of rare diseases. Further, the committee also noted that there is an unmet medical need in the country.
Antihemophilic factor (AHF), also known as Factor VIII, is a protein essential for blood clotting, and its deficiency leads to hemophilia A, a bleeding disorder. AHF is used to prevent or control bleeding in patients with hemophilia A by increasing the levels of this clotting factor in the blood.
Antihemophilic Factor binds factor IXa along with calcium and phospholipid. This complex converts factor X to factor Xa to facilitate clotting cascade. Antihemophilic factor (AHF) is a protein found in normal plasma that is necessary for clot formation.
At the recent SEC meeting for hematology held on 6th March 2025, the expert panel reviewed the safety and efficacy data from the clinical studies conducted globally along with subset analysis of subjects participating from Asian countries and safety data in comparison with other Factor VIII drugs used in the centers where HFI donated the drug for a grant of permission to import and market the drug Antihemophilic Factor (Recombinant Factor VIII) 250, 500, 1000, 2000, and 3000 IU Lyophilized Powder for Solution for Intravenous Injection (Octocog alfa).
After detailed deliberation, the committee recommended granting permission for the import and marketing of the drug with a waiver of the Phase III clinical trial, with the condition to conduct a Phase IV study.
Accordingly, the expert panel suggested that the firm should submit the Phase IV study protocol within three months of approval of the product.
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