AstraZeneca Pharma India bags nod for selumetinib

The Indian subsidiary of UK pharma major AstraZeneca (LSE: AZN) has gained approval from the Drugs Controller General of India (DCGI) to import and market selumetinib capsules, indicated for pediatric patients with neurofibromatosis type 1.

Selumetinib, which is approved in the USA and Europe under the trade name Koselugo, is used for the treatment of patients three years of age and older with neurofibromatosis type 1 (NF1) and who have symptomatic, inoperable plexiform neurofibromas (PN). Selumetinib is in a class of medications called kinase inhibitors and works by blocking the action of the abnormal protein that signals the tumors to grow.

"The receipt of this permission paves the way for the launch of selumetinib 10mg and 25mg capsules in India," AstraZeneca said in a regulatory filing.

The company, which reported a 45.03% decline in its net profit for the June ended quarter, is in the midst of mobilizing research efforts to advance the development of a novel coronavirus-neutralizing long-acting antibody combination (LAAB) for the potential prevention and treatment of COVID-19.

Other recent developments in India

In March, the company received marketing approval from the DCGI for its non-small cell lung cancer drug Tagrisso (osimertinib). The regulatory approval in India will provide better medicine for the management of non-small cell lung cancer and help patients attain a better quality of life, said AstraZeneca India managing director Gagandeep Singh Bedi.

At the end of December last year, AstraZeneca teamed up with Mumbai-based Qure.ai, a healthcare start-up to integrate innovative artificial intelligence (AI) solutions for the early detection of lung cancer in patients across India.