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