Benralizumab receives DCGI approval for the management eosinophilic asthma

December 23, 2020 0 By FM

AstraZeneca’s benralizumab (Fasenra) solution has received authorisation from the Drugs Controller General of India (DCGI) for treating severe asthma patients.

Benralizumab is not an inhaler or steroid and is administered once in 8 weeks subcutaneously via injection. It is available in a single-dose prefilled syringe 30 mg/ml solution. It is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients.

Asthma is a common, heterogeneous, chronic inflammatory disease of the airways that affects people of all ages and imposes a substantial burden on patients, their families, and the community. It causes respiratory symptoms that are interspersed with – attacks of breathlessness, which may require urgent health care and may result into emergency admission in hospital or sometimes fatal.

The Indian Study on Epidemiology of Asthma, Respiratory Symptoms and Chronic Bronchitis (INSEARCH) done from 12 urban and 11 rural sites in India estimated the prevalence of asthma in India to be 2.05% among those aged >15 years, with an estimated national burden of 18 million asthmatics.

Another study showed that 58% Indian patients with asthma have increased peripheral eosinophil with 26.3% of patients having abnormal sputum eosinophil count. 50% of severe asthmatics patients have exacerbations (asthma attacks) and symptoms with the presence of persistent high eosinophils despite taking high-dose inhaled steroids (standard of care inhaled medicine).

Benralizumab is already approved in 58 countries for the management of eosinophilic asthma. The drug is designed to target eosinophils, which are a key cause of the eosinophilic subtype of asthma. Studies have also shown that patients on benralizumab could reduce their oral steroid intake significantly and therefore reducing the potential steroid-related side-effects, said AstraZeneca.

The marketing authorisation from DCGI paves the way for launch of benralizumab in India subject to other requisite regulatory approvals.