Expert Panel Approves Post-Marketing Surveillance Study of Eculizumab (Soliris) by AstraZeneca in India
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to AstraZeneca Pharma India Ltd to conduct a Post Marketing Surveillance (PMS) study for its monoclonal antibody drug Eculizumab (Soliris) in India.
As per the official minutes, “The firm presented the proposal to conduct the Post Marketing Surveillance Study (PMS) in India for Eculizumab concentrate for solution for infusion 300 mg (10mg/ml) (Soliris) titled ‘A Prospective, Observational, Multicenter, Post Marketing Surveillance Study to assess safety of Eculizumab in Indian patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)’ vide study code D7414R00002 Version 1.0 dated 09.04.2025 as per the condition of Marketing Authorization approval.”
Following detailed deliberation during the SEC (Hematology) meeting held on 28th May 2025, the committee stated:
“After detailed deliberation, the committee recommended for grant of permission to conduct the Post Marketing Surveillance Study (PMS) as per the protocol presented by the firm.”
Eculizumab is a humanized monoclonal antibody that targets complement protein C5. By binding to this protein, it prevents activation of the terminal complement cascade, a critical mechanism in several rare and severe autoimmune diseases. The drug is approved for treating Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS).
The PMS study will assess the real-world safety of Eculizumab in Indian patients diagnosed with PNH, as part of the firm’s post-marketing obligations under its Marketing Authorization.
