AstraZeneca Gets CDCSO Panel Nod To Import, Market Eculizumab To Treat Paroxysmal Nocturnal Hemoglobinuria
Keeping in mind that there is an unmet medical need in India, the Topic Specialist Board (SEC) functional under the Central Drug Requirement Control Organisation (CDSCO) has provided approval to the medication significant AstraZeneca to import and market Eculizumab Concentrate for remedy for mixture 300 mg for the therapy of individuals with Paroxysmal nighttime hemoglobinuria (PNH) subject to the condition that the firm should perform Active Postmarketing surveillance (PMS) study.
This followed AstraZeneca Pharma provided the proposal for a grant of permission to import and market Eculizumab concentrate for service for infusion 300 mg for the indication “the therapy of clients with Paroxysmal nocturnal hemoglobinuria (PNH)” along with a request for local professional trial waiver.
The board kept in mind that the medicine drops under the classification of orphan drug and there is an unmet requirement in India. The medication is approved in the US and other nations.
Eculizumab is a long-acting humanized monoclonal antibody targeted versus enhance C5. It hinders the cleavage of C5 right into C5a and C5b and thus prevents deployment of the incurable complement system consisting of the formation of MAC.
Eculizumab shot is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red cell are broken down in the body, so there are inadequate healthy cells to bring oxygen to all parts of the body).
At the recent SEC conference for Haematology hung on 18th April 2024, the specialist panel reviewed the proposal for a give of authorization to import and market Eculizumab concentrate for option for mixture 300 mg for the indication “the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH)” along with an ask for regional scientific trial waiver.
After in-depth deliberation, the board recommended a grant of authorization to import and market the medication for indication i.e., “the therapy of clients with Paroxysmal nocturnal hemoglobinuria (PNH)” based on the firm’s problem to conduct an Active PMS research.
As necessary, the expert panel suggested that the company must send the Active PMS research study protocol to CDSCO within 03 months of Marketing Authorization for testimonial by the board
