AstraZeneca Pharma India Receives CDSCO Nod
Friday, 30 May 2025, 10:22 IST
• AstraZeneca Pharma India has received CDSCO approval to import Benralizumab (Fasenra).
• Already approved for severe eosinophilic asthma, this expands its therapeutic use in India.
• Fasenra targets eosinophils and offers a new treatment option for this rare autoimmune disease.
AstraZeneca Pharma India Limited has announced that it has obtained regulatory authorization from the Central Drugs Standard Control Organisation (CDSCO). Under the Directorate General of Health Services, Government of India, to import Benralizumab 30 mg/ml Solution for Injection for a new indication.
With this latest approval, Benralizumab (Fasenra) is now approved as an additional treatment option for adult patients diagnosed with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Fasenra, a monoclonal antibody that targets and reduces eosinophil levels, has already been authorized in India for the management of severe eosinophilic asthma.
The newly approved indication broadens its therapeutic applications and provides a significant treatment alternative for patients with EGPA. The company expressed that this approval marks a major achievement in its dedication to delivering innovative biologics to individuals with rare and challenging-to-treat conditions in India. “This approval facilitates the marketing of Fasenra for this new indication, pending the acquisition of any necessary related statutory approvals”, stated AstraZeneca Pharma India in a press release.
EGPA, previously referred to as Churg-Strauss Syndrome, is an autoimmune disorder that can impact various organ systems, such as the lungs, skin, gastrointestinal tract, and nervous system. Managing this condition can be complex, but the availability of Fasenra as a targeted therapy brings renewed hope for individuals with relapsing or refractory variants of the disease.
Benralizumab is delivered via subcutaneous injection and functions by attaching to the IL-5 receptor on eosinophils, resulting in their swift depletion through antibody-dependent cell-mediated cytotoxicity (ADCC). This action aids in regulating the inflammatory response linked to EGPA. AstraZeneca enhances its position in the biologics sector in India, striving to offer innovative therapeutic options for patients dealing with a range of respiratory and immunological disorders.
• Already approved for severe eosinophilic asthma, this expands its therapeutic use in India.
• Fasenra targets eosinophils and offers a new treatment option for this rare autoimmune disease.
AstraZeneca Pharma India Limited has announced that it has obtained regulatory authorization from the Central Drugs Standard Control Organisation (CDSCO). Under the Directorate General of Health Services, Government of India, to import Benralizumab 30 mg/ml Solution for Injection for a new indication.
With this latest approval, Benralizumab (Fasenra) is now approved as an additional treatment option for adult patients diagnosed with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Fasenra, a monoclonal antibody that targets and reduces eosinophil levels, has already been authorized in India for the management of severe eosinophilic asthma.
The newly approved indication broadens its therapeutic applications and provides a significant treatment alternative for patients with EGPA. The company expressed that this approval marks a major achievement in its dedication to delivering innovative biologics to individuals with rare and challenging-to-treat conditions in India. “This approval facilitates the marketing of Fasenra for this new indication, pending the acquisition of any necessary related statutory approvals”, stated AstraZeneca Pharma India in a press release.
EGPA, previously referred to as Churg-Strauss Syndrome, is an autoimmune disorder that can impact various organ systems, such as the lungs, skin, gastrointestinal tract, and nervous system. Managing this condition can be complex, but the availability of Fasenra as a targeted therapy brings renewed hope for individuals with relapsing or refractory variants of the disease.
Benralizumab is delivered via subcutaneous injection and functions by attaching to the IL-5 receptor on eosinophils, resulting in their swift depletion through antibody-dependent cell-mediated cytotoxicity (ADCC). This action aids in regulating the inflammatory response linked to EGPA. AstraZeneca enhances its position in the biologics sector in India, striving to offer innovative therapeutic options for patients dealing with a range of respiratory and immunological disorders.
