The drug is used in treating atypical Haemolytic Uremic Syndrome (aHUS) and Paroxysmal Nocturnal Hemoglobinuria (PNH)
AstraZeneca India announced the official launch of Eculizumab concentrate solution for infusion (300 mg,10 mg/ml) in India. This follows the Central Drugs Standard Control Organisation (CDSCO) approval received in January 2025 for the import, sale, and distribution of the product.
With this development, Eculizumab is now the first anti-complement therapy authorised in India for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS) in both adults and children.
Both aHUS and PNH are ultra-rare, life-threatening disorders caused by chronic, uncontrolled activation of the complement system, leading to severe complications in blood and kidney health.
aHUS is an ultra-rare, progressive disorder triggered by, uncontrolled activation of the complement system, leading to thrombotic microangiopathy (TMA)- the formation of blood clots in small vessels.
Praveen Akkinepally, Country President and Managing Director, AstraZeneca India, said, “The launch of Eculizumab as India’s first approved anti-complement therapy demonstrates our dedication to delivering innovative medicines at the earliest opportunity, especially where there is a significant unmet medical need. By bringing forward transformative therapies, we strive to give patients in India timely access to advances that can change lives and improve long-term outcomes. This milestone reflects our continued commitment to expanding our access and making a meaningful difference for people living with rare diseases.”
The launch of Eculizumab in India aligns with AstraZeneca’s ambition to transform outcomes in rare and complex diseases through pioneering science and early intervention.
