AstraZeneca gets CDSCO Panel Nod To Import, Market Palivizumab solution for injection
New Delhi: Pharmaceutical major AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to import and market Palivizumab to treat serious lower respiratory tract infection (LRTI) caused by the respiratory syncytial virus (RSV).
This came after AstraZeneca presented its proposal for a grant of permission to import and marketing of Palivizumab 50 mg/0.5 ml & 100 mg/ml solution for injection with a local clinical trial waiver under unmet medical needs indicated for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children at high risk of RSV disease.
ï‚· Infants born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
ï‚· Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months.
ï‚· Children less than 2 years of age and with hemodynamically significant congenital heart disease (CHD)
Palivizumab is a monoclonal anti respiratory syncytial virus F protein antibody used to prevent serious sequelae caused by respiratory syncytial virus infection in pediatric patients.
Palivizumab, a recombinant humanized monoclonal antibody that provides passive immunity against RSV, acts by binding the RSV envelope fusion protein (RSV F) on the surface of the virus and blocking a critical step in the membrane fusion process. Palivizumab binds to the fusion glycoprotein of RSV. This prevents its binding and uptake by host cellular receptors.
At the recent SEC meeting for Pulmonary held on 08.08.2023 at CDSCO, the expert panel reviewed the proposal presented by AstraZeneca for a grant of permission to import and marketing of Palivizumab 50 mg/0.5 ml & 100 mg/ml solution for injection with a local clinical trial waiver.
The committee noted that the drug is approved in 86 countries globally including the USA, UK, and Japan.
After detailed deliberation, the committee recommended for grant of permission for the import and marketing of Palivizumab 50 mg/0.5 ml & 100 mg/ml solution for injection with a local clinical trial waiver subject to the condition that the firm shall conduct the Phase-IV study in India.
Accordingly, the expert panel suggested that the firm should submit the protocol to conduct the Phase-IV study within 3 months of approval of the marketing authorization.
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