Japanese OK In COPD Gives AstraZeneca’s Breztri Aerosphere First Regulatory Approval
AstraZeneca’s respiratory chief tells Scrip Japan’s approval of the triple-combination inhaled therapy is both a milestone for treating COPD and for the UK pharma’s strategy.
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Despite the emergence of the coronavirus pandemic at the end of the period, Japan’s regulatory authorities maintained an annual pace of new drug approvals on a par with the previous year, with expedited programs helping several drugs to market.
Glenmark rolls out three-in-one inhaler therapy for COPD in India and hopes to address challenges faced by patients suffering from the severe form of the disease. Some early physician outlook appears mixed for the new combination in a segment where leading respiratory player Cipla has an established product.
Issued with a complete response letter from the FDA, the company says it will now submit newer data showing the combination's effects on exacerbations.