Novo Nordisk Gets CDSCO Panel Nod To Import, Market Concizumab Injection

New Delhi: Citing that there is unmet medical need in the country for the proposed indication, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Novo Nordisk India for the import and marketing of the drug Concizumab Injection 15 mg/1.5 ml, 60 mg/1.5 ml, 150 mg/1.5 ml and 300 mg/3 ml solution for injection in a pre-filled pen for routine prophylaxis of bleeding in patients with hemophilia A with FVIII inhibitors and hemophilia B with FIX inhibitors.

This approval is conditional on the firm conducting a post-marketing surveillance (PMS) study in India for the specified indications and submitting the PMS study protocol within three months of the approval.

The committee further recommended that the firm develop procedures and testing facilities for reporting drug levels to the prescribing physician.

This came after the firm presented their proposal for grant of permission for import and marketing of drug Concizumab Injection (15 mg/1.5 ml, 60 mg/1.5 ml, 150 mg/1.5 ml and 300 mg/3 ml) solution for injection in a pre-filled pen based on global clinical trials including Indian patients.

Concizumab is a humanized IgG4 monoclonal antibody targeting the Kunitz-2 domain of tissue factor pathway inhibitor (TFPI), a key regulator of the coagulation cascade

Concizumab is a monoclonal antibody antagonist specific for the Kunitz-2 domain of tissue factor pathway inhibitor (TFPI). Under normal circumstances, TFPI acts to attenuate the coagulation cascade by inhibiting the extrinsic (aka initiation) coagulation pathway, allowing the intrinsic (aka amplification) pathway to take over. In patients with hemophilia, which is characterized by deficiencies in the intrinsic coagulation pathway, the inhibition of TFPI enhances the production of factor Xa during the initiation phase of the coagulation pathway, improving thrombin generation and clot formation.

At the recent SEC meeting for Oncology held on 11th February 2025, the expert panel reviewed the proposal for grant of permission for import and marketing of drug Concizumab Injection 15 mg/1.5 ml, 60 mg/1.5 ml, 150 mg/1.5 ml and 300 mg/3 ml Solution for injection in Pre-filled pen based on global clinical trials including Indian patients.

The expert panel noted that the proposed drug is indicated for routine prophylaxis of bleeding in patients with

1. Haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more.

2. Haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.

The committee further noted that the drug falls under the orphan drug category and indicated for the rare disease. The committee also noted that there is unmet medical need in the country for the proposed indication.

After detailed deliberation, the committee recommended the grant of permission to import and market drugs with the following conditions:

1. The firm should conduct PMS studies for the proposed indications in India. Accordingly, the firm should submit PMS study protocol within three months of approval.

2. The firm should develop procedures and testing facilities for reporting drug levels to the prescribing physician.

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