New Delhi: Pharmaceutical major Sanofi Healthcare India has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSCO to import and market Nirsevimab solution for injection in prefilled syringes 50mg and 100mg indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease.
This came after the drug maker Sanofi Healthcare presented the proposal for a grant of permission to import and market Nirsevimab solution for injection in prefilled syringes 50mg and 100mg with local clinical trial waiver under unmet medical need indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:
• Neonates and infants born during or entering their first RSV season.
• Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The committee noted that the drug is approved in several countries globally including the USA, UK, Canada, and EU.
Nirsevimab is a long-acting monoclonal antibody indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants.
Nirsevimab is a recombinant human immunoglobulin G1 kappa (IgG1ĸ) long-acting monoclonal antibody that binds to the prefusion conformation of the respiratory syncytial virus (RSV) F protein. RSV is coated with two types of glycoproteins, the attachment glycoprotein (G protein) and the fusion glycoprotein (F protein). Of these two, only the F protein is essential for the entry of the virus into cells lining the respiratory tract, making it a desirable drug target. The RSV F protein is initially in a metastable prefusion conformation and undergoes conformational changes after being triggered by an unknown event. These conformational changes lead to a postfusion conformation, where both viral and host-cell membranes are together.
Nirsevimab binds to a highly conserved epitope of the RSV prefusion F protein, inhibiting the membrane fusion step in the viral entry process. This allows nirsevimab to neutralize various RSV A and B strains and block cell-to-cell fusion.
At the recent SEC meeting for Pulmonary meeting held on 5th March 2024, the expert panel reviewed the proposal presented by the drug major Sanofi for the import and market of Nirsevimab solution for injection in prefilled syringe 50mg and 100mg with local clinical trial waiver under unmet medical need indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease.
After detailed deliberation, the committee recommended the grant of permission for the import and marketing of Nirsevimab solution for injection in prefilled syringes 50mg and 100mg with local clinical trial waiver subject to the condition that the firm should conduct a Phase-IV study for assessing the efficacy and safety in Indian population.
Accordingly, the expert panel suggested that the firm should submit the protocol to conduct a Phase-IV study within 3 months of approval of marketing authorization.
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