AstraZeneca Gets CDCSO Panel Nod to Import, market Eculizumab to treat Paroxysmal Nocturnal Hemoglobinuria

New Delhi: Noting that there is an unmet medical need in India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major AstraZeneca to import and market Eculizumab Concentrate for solution for infusion 300 mg for the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH) subject to the condition that the firm should conduct Active Postmarketing surveillance (PMS) study.

This came after AstraZeneca Pharma presented the proposal for a grant of permission to import and market Eculizumab concentrate for solution for infusion 300 mg for the indication “the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH)” along with a request for local clinical trial waiver.
The committee noted that the drug falls under the category of orphan drug and there is an unmet need in India. The drug is approved in the US and other countries.

Eculizumab is a long-acting humanized monoclonal antibody targeted against complement C5. It inhibits the cleavage of C5 into C5a and C5b and hence inhibits deployment of the terminal complement system including the formation of MAC.

Eculizumab injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body).

At the recent SEC meeting for Haematology held on 18th April 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 “the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH)” along with a request for local clinical trial waiver.
After detailed deliberation, the committee recommended a grant of permission to import and market the drug for indication i.e., “the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH)” subject to the firm’s condition to conduct an Active PMS study.
Accordingly, the expert panel suggested that the firm should submit the Active PMS study protocol to CDSCO within 03 months of Marketing Authorization for review by the committee

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