AstraZeneca gets DCGI nod for asthma drug

NEW DELHI: Drug firm AstraZeneca India on Tuesday said it has received marketing authorisation for an asthma drug from the Drugs Controller General of India (DCGI).

The company has received approval from the DCGI for Fasenra (Benralizumab solution for injection in a single dose prefilled syringe30 mg/ml) for patients with severe asthma (eosinophilic asthma), AstraZeneca India said in a statement.

Benralizumab (Fasenra) is indicated as an add-on treatment for severe asthma with an eosinophilic phenotype in adult patients, it added.


“The drug firm has always been at the forefront of innovative solutions for non-communicable diseases. Despite currently available therapies, a significant unmet need for effective management of severe Asthma continues to exist globally as well as in India," AstraZeneca India Managing Director Gagandeep Singh Bedi said.

The regulatory approval of Fasenra in India will provide better medicine for the management of eosinophilic asthma and support patients to attain a better quality of life, he added.