CDSCO approves AstraZeneca’s anti-complement medicine Eculizumab

AstraZeneca Pharma India announces a Central Drugs Standard Control Organisation (CDSCO) permission to import, sell or distribute ‘Eculizumab’ concentrate solution for infusion 300 mg (10mg/ml).

Eculizumab is an anti-complement medical therapy indicated for treating two rare conditions- Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS), both in children and adults.

PNH is a life-threatening disease characterised by thrombosis, end organ damage and impaired quality of life due to chronic haemolysis. Historical global data reveals poor survival rates, with 72 per cent of patients dying within 25 years of diagnosis and without timely diagnosis and treatment options, patients face increased risks of complications such as thrombosis, renal impairment and premature mortality. 

aHUS, on the other hand, presents a grave unmet medical need in India, marked by devastating clinical manifestations, including thrombotic microangiopathy (TMA), acute renal failure, neurological complications, and multi-organ damage. These presentations often result in prolonged hospitalisations, increased healthcare costs, and substantial morbidity.

AstraZeneca completed the acquisition of Alexion in 2021 and continues to expand its portfolio with the aim of bringing innovative therapies for patients living with rare diseases in India.