AstraZeneca gets CDSCO nod for new indications of Benralizumab, Osimertinib in India

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-05-30T13:00:45+05:30 | Updated On 30 May 2025 1:00 PM IST

Bangalore: AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Government of India, to import for sale and distribution of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) and Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for an additional indication in India.

With this approval, Benralizumab is now indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare autoimmune disease that causes inflammation of small- to medium-sized blood vessels, often affecting the lungs, skin, and nerves.

Additionally, Osimertinib has been approved as a monotherapy for the treatment of patients with locally advanced, unresectable (stage III) Non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy. NSCLC is the most prevalent form of lung cancer, typically characterized by a slower growth and spread compared to small cell lung cancer.

The company stated that this regulatory nod paves the way for the marketing of Benralizumab and Osimertinib in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.

Earlier, in April 2025, the Medical Dialogues team reported that AstraZeneca had received CDSCO permission to import for sale and distribute Osimertinib Tablets 40 mg and 80 mg (Tagrisso) for another additional indication. That approval allows Osimertinib to be used in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited is the operating company and covers manufacturing, sales and marketing activities of the company in India.

It is a listed company and is a subsidiary of AstraZeneca Plc, UK.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751