The Central Drugs Standard Control Organization (CDSCO)'s, Pulmonary Subject Expert Committee (SEC) during its meeting held on December 05, 2017, at CDSCO Headquarters New Delhi, granted permission to Novartis to conduct clinical trial for its asthma drug (QAW039-Fevipiprant) which is currently in development phase globally. The SEC opined that there is an unmet need in the country, and the test drug may be an alternative treatment option in patients with uncontrolled severe asthma13.
After detailed deliberation, the committee concluded that the risk versus benefit to the patients justified the approval for a clinical trial. The safety profile of the test drug from various pre-clinical toxicities including single dose, repeat dose, genotoxicity and clinical phase I, II studies also justified the conduct of the study since this provides innovation vis-a-vis existing therapeutic option.
The purpose of the study will be to demonstrate the efficacy of QAW039 150 mg once daily as measured by change from baseline in pre-dose FEV1 [in liters], compared with placebo, at the end of the 12-week active treatment period.
QAW039 (fevipiprant) is CRTH2 antagonist, which is currently in phase III of drug development; Novartis is intending to file the drug in 201914. Phase III of drug development consists of large-scale clinical studies, covering several hundred to several thousand patients, which are conducted to establish the safety and efficacy of the drug in specific indications for regulatory approval. Phase III trials also may be used to compare a new drug against a current standard of care to evaluate the overall benefit-risk relationship of the new medicine.
What is asthma?
Asthma attacks all age groups but often starts in childhood. It is a disease characterized by recurrent attacks of breathlessness and wheezing, varying in severity and frequency from person to person. This condition is due to inflammation of the air passages in the lungs and affects the sensitivity of the nerve endings in the airways, so they become easily irritated. During an attack, the lining of the passages swells, causing constriction of the airways thereby reducing the inflow and outflow of air from the lungs.
According to the World Health Organization (WHO), India has an estimated 15-20 million asthmatics, with further estimates indicating the prevalence of asthma to be between 10% and 15% in 5-11 years old children15.
QAW039 (Fevipiprant) is a promising drug for relief in patients with uncontrolled severe asthma. Researchers have hailed this drug as a game-changer in asthma treatment after a Lancet-published trial showed its potential to significantly reduce the severity of the condition16. Also the possibility of taking a pill instead of using an inhaler will be a very welcome one among patients with asthma, some of whom may struggle with the complexities required to use/operate an inhaler device.
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