AstraZeneca’s Asthma drug Benralizumab gets marketing approval from DCGI

AstraZeneca India has received marketing authorisation from Drugs Controller General of India (DCGI) for its research medicine, Fasenra (Benralizumab) for patients with severe asthma (eosinophilic asthma). The DCGI approval is for the injection solution which is in a single dose prefilled syringe 30 mg/ml and for subcutaneous administration only.

Benralizumab is indicated as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients.

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

Another study showed that 58 per cent Indian patients with asthma have increase peripheral eosinophil (a type of blood cells) with 26.3 per cent patients having abnormal sputum eosinophil count. 50 per cent 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).

According to the company’s press release, with the approval of Fasenra in India, the medical fraternity has a better option that is already approved in 58 countries (as on August 2020) at their disposal for the management of eosinophilic asthma. Fasenra is an add-on maintenance treatment for patients with severe eosinophilic asthma. It is designed to target cells in the body called eosinophils, which are a key cause of the eosinophilic subtype of asthma. Fasenra is not an inhaler or a steroid and is administered once in eight weeks under the skin via injection as maintenance therapy. Studies have also shown that patients on Fasenra could reduce their oral steroid intake significantly and therefore reducing the potential steroid-related side-effects. The marketing authorisation from DCGI paves the way for launch of Fasenra in India subject to other requisite regulatory approvals.

Gagandeep Singh Bedi, Managing Director, AstraZeneca India, said, “AstraZeneca 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. 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”.

Dr Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said, “The marketing authorisation for Fasenra in India is based on the evidence collated over years, phase III trials conducted globally on more than 11,000 patients, and patient exposure of more than 56000 patient years. Fasenra is a medically differentiated biologic with unique mechanism of targeting the IL-5 receptors, which has shown a rapid reduction of blood eosinophils after the first dose, resulting in better management of eosinophilic asthma .”