AstraZeneca Pharma India Gets CDSCO Panel Nod To Import, Market Eculizumab for Atypical hemolytic uremic syndrome
New Delhi: The drug major AstraZeneca Pharma 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 the drug Eculizumab concentrate for solution for infusion 300 mg for indication of “Atypical hemolytic uremic syndrome (aHUS)”.
However, this approval is subject to the condition that Astra Zeneca Pharma India should conduct a Phase IV Clinical trial to establish the safety and effectiveness of the drug in the Indian population.
This came after Astra Zeneca Pharma India presented the proposal for a grant of permission to import and market Eculizumab concentrate for solution for infusion 300 mg for the indication “Atypical hemolytic uremic syndrome (aHUS)” with a request for waiver of a local clinical trial. In addition, the firm has presented the global clinical trial data.
Atypical hemolytic uremic syndrome (aHUS) is a very rare genetic disease that causes tiny blood clots to form in blood vessels, blocking blood flow to important organs. aHUS can cause kidney failure, heart disease, and other serious health problems.
Eculizumab is a recombinant humanized monoclonal antibody used to reduce the risk of hemolysis in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Eculizumab is a monoclonal antibody that targets complement protein C5, preventing cleavage to C5a and C5b, and the formation of the terminal complement complex C5b-9. Inhibition of this complex prevents complement-mediated intravascular hemolysis in paroxysmal nocturnal hemoglobinuria, complement-mediated microangiopathy in atypical hemolytic uremic syndrome, and immune-mediated inflammation and damage of the central nervous system in neuromyelitis optica spectrum disorder.
At the recent SEC meeting Renal held on 21st May 2024, the expert panel reviewed the proposal for a grant of permission to import and market Eculizumab concentrate for solution for infusion 300 mg for the indication “Atypical hemolytic uremic syndrome (aHUS)” with a request for waiver of a local clinical trial.
The committee noted that the drug is proposed for the treatment of rare diseases and there is an unmet medical need in India. The indication is approved in the US and other countries.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug Eculizumab concentrate for solution for infusion 300 mg for indication of “Atypical hemolytic uremic syndrome (aHUS)” with the waiver of Phase III clinical trial along with following conditions
1) The firm should conduct a Phase IV Clinical trial to establish the safety and effectiveness of the drug in the Indian population.
2) The proposed indication should be aligned with the U.S. Food and Drug Administration (USFDA) approved indication. The firm should submit the modified indication in line with the approved indication to CDSCO.
3)The drug should be prescribed for the indication of “Atypical hemolytic uremic syndrome (aHUS)” based on the recommendation of centre of Excellence (CoE) Institutions only.
Accordingly, the expert panel suggested that the firm should submit the Phase IV protocol to CDSCO within 03 months of Marketing Authorization for review by the committee.
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