AstraZeneca’s Benralizumab (Fasenra™) Receives Regulatory Approval in India for the Management of Patients with Severe Asthma

With close to 4 Crore Asthma patients in India, the government approval of Fasenra™ (Benralizumab) will provide much-needed treatment support for severe asthma patients

22 December 2020, Bangalore, India: AstraZeneca India (AstraZeneca Pharma India Limited), a leading science-led biopharmaceutical company, announced a great news for Severe Asthma patients on getting marketing authorisation from Drugs Controller General of India (DCGI) for - use of the original research medicine, Fasenra™ (Benralizumab solution for injection in a single dose prefilled syringe30 mg/ml subcutaneous administration only ) in patients with severe asthma (eosinophilic asthma).  Benralizumab (Fasenra™) is 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 burden of asthma is immense as it causes limitations in daily activities, loss of school and work days, lung function impairment, reduced quality of life, and an adverse socioeconomic burden.2

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.2 Another study showed that 58% Indian patients with asthma have increase peripheral eosinophil (a type of blood cells) with 26.3% 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).3

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 8 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, 6 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 .”

 

About AstraZeneca Pharma India Limited

AstraZeneca Pharma India Limited (AstraZeneca India) was established in 1979 and is marking its 40th year of long-standing commitment to patients in India. It is headquartered at Bengaluru, Karnataka. AstraZeneca India has a workforce of over 1,400 employees across the country committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization. For more information, please visit: https://www.astrazeneca.in/

About AstraZeneca

 

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.com and follow us on Twitter @AstraZeneca.

 

Reference:

1.       The global asthma report 2018. Accessed from: http://www.globalasthmareport.org/management/india.php

2.       Koul PA, Patel D. Indian guidelines for asthma: Adherence is the key. Lung India. 2015;32(Suppl 1): S1-S2. doi:10.4103/0970-2113.154511

Kumar RM, Pajanivel R, Koteeswaran G, Menon SK, Charles PM. Correlation of total serum immunoglobulin E level, sputum, and peripheral eosinophil count in assessing the clinical severity in bronchial asthma. Lung India. 2017;34(3):256-261. doi:10.4103/lungindia.lungindia_73_16. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5427754/