AstraZeneca Gets CDSCO Panel Nod To study Tezepelumab
New Delhi: Pharmaceutical major AstraZeneca Pharma India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of Tezepelumab.
This came after AstraZeneca Pharma India presented phase III clinical study protocol no. D5241C00006 CSP version 1.0 dated 02 Dec 2024 and Local CSP Addendum IND-1 version 1.0 dated 03 Jan 2025.
Tezepelumab is a human monoclonal antibody used to treat severe asthma, specifically targeting thymic stromal lymphopoietin (TSLP) to reduce airway inflammation and asthma exacerbations.
Tezepelumab was developed as a biologic with a unique mechanism of action that involves inhibiting the action of thymic stromal lymphopoietin (TSLP). This epithelial cytokine activates a wide range of immune cells involved in airway inflammation in asthma
At the recent SEC meeting for Pulmonary held on 11th March 2025, the expert panel reviewed phase III clinical study protocol no. D5241C00006 CSP version 1.0 dated 02 Dec 2024 and Local CSP Addendum IND-1 version 1.0 dated 03 Jan 2025.
After detailed deliberation, the committee recommended granting permission to conduct the trial as presented by the firm.
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