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.
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).
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