Bayer Pharmaceutical Gets CDSCO Panel Nod To Import, Market Recombinant Factor VIII

New Delhi: Bayer Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the product Antihemophilic Factor (Recombinant Factor VIII) PEGylatedaucl 500 IU/1000 IU/2000 IU/3000 IU (Damoctocog Alfa Pegol) with the condition to conduct a Phase-IV study in India

This came after Bayer Pharmaceutical presented the proposal for a grant of permission to import and market the drug Antihemophilic Factor (Recombinant Factor VIII) PEGylated-aucl 500 IU/1000 IU/2000 IU/3000 IU (Damoctocog Alfa Pegol) with a request for a waiver of Phase-III and Phase-IV clinical studies.

The firm is claiming that the drug product has been used in India since the year 2020 by donation through the World Hemophilia Association (WHA) to the Hemophilia Federation of India (HFI) on compassionate grounds. More than 13 million units of drug product have been used as of the date.

The committee noted that the drug is currently approved in 53 countries, including the USA, the EU, the UK, Australia, Canada, and Japan.

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) is a protein that is produced naturally in the body. It helps the blood form clots to stop bleeding and prevents bleeding problems from happening as often. Hemophilia A, also called classical hemophilia, is a condition where the body does not make enough AHF.

Antihemophilic factor VIII and von Willebrand factor injection is a combination product that is used to treat serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD). The bleeding episode may be related to an injury (trauma) or a surgical procedure.

At the recent SEC meeting on 6th March 2025, the expert panel reviewed the proposal for the grant of permission to import and market the drug Antihemophilic Factor (Recombinant Factor VIII) PEGylated-aucl 500 IU/1000 IU/2000 IU/3000 IU (Damoctocog Alfa Pegol) with a request for a waiver of Phase-III and Phase-IV clinical studies.

After detailed deliberation, the committee recommended granting permission to import and market the product Antihemophilic Factor (Recombinant Factor VIII) PEGylated-aucl 500 IU/1000 IU/2000 IU/3000 IU (Damoctocog Alfa Pegol) with the condition to conduct a Phase IV study in India.

Accordingly, the expert panel suggested that the firm should submit a Phase-IV study protocol within 3 months of import and marketing permission.

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