Thrilling News for Asthma Patients: AstraZeneca India Gets Green Signal for Benralizumab Import

AstraZeneca Pharma India Ltd. has received regulatory approval to import Benralizumab (Fasenra) for an additional indication, marking a significant advancement in respiratory care for Indian patients. The Central Drugs Standard Control Organisation (CDSCO) granted this permission, paving the way for broader access to this innovative biologic therapy.

 

Key Highlights:

 

Benralizumab (Fasenra) is a monoclonal antibody designed as an add-on maintenance treatment for adults with severe asthma characterized by an eosinophilic phenotype, a condition often resistant to standard therapies.

 

The latest approval extends the scope of Benralizumab’s use in India, following its initial authorization for severe asthma, and is supported by a post-marketing Phase 4 safety study to be conducted in the Indian population.

 

With nearly 40 million asthma patients in India, this move is expected to significantly improve disease management for those who struggle with severe, uncontrolled symptoms despite conventional treatments.

 

Fasenra offers a unique mechanism of action by targeting and depleting eosinophils, a key driver of inflammation in this asthma subtype, and is administered via subcutaneous injection once every eight weeks—reducing the need for frequent dosing and potentially lowering reliance on oral steroids.

 

AstraZeneca’s commitment to innovation and patient-centric solutions is underscored by this regulatory milestone, promising better quality of life for patients and new options for healthcare providers.

 

This expanded approval reinforces AstraZeneca’s leadership in respiratory medicine and brings renewed optimism for patients battling severe asthma across India.

 

Sources: Economic Times, AstraZeneca India, CDSCO