AstraZeneca plc. AZN announced that its triple combination therapy, a combination of budesonide, glycopyrronium and formoterol fumarate, has been approved by the National Medical Products Administration of China as maintenance treatment for chronic obstructive pulmonary disease (“COPD”). The therapy had been approved in Japan in June with the trade name of Breztri Aerosphere for a similar indication. The COPD therapy, which is known as PT010 outside China, is under review in the United States and Europe.
We note that budesonide is an ICS, glycopyrronium is a long-acting muscarinic antagonist (“LAMA”) and formoterol fumarate is a long-acting beta-agonists (“LABA”) therapy. PT010 can be delivered using AstraZeneca’s Aerosphere Delivery Technology.
The approval is based on positive data from the KRONOS study, which compared PT010 to dual combination therapies — Bevespi Aerosphere and PT009 — in COPD. The study demonstrated that PT010 led to a statistically-significant improvement in trough forced expiratory volume in one second (FEV1), a measure of lung function and the primary endpoint for China, versus the dual combination therapies.
Please note that the FDA had given a complete response letter (“CRL”) to AstraZeneca’s new drug application (“NDA”) for PT010 in October. The NDA was filed based on data from the KRONOS study. The company is working closely with the FDA to resolve the issues mentioned in the CRL. It will also submit positive data from another phase III study, ETHOS, which was incomplete at the time of the NDA submission. Data from the ETHOS previously announced showed that PT010 achieved a statistically-significant reduction in the rate of moderate or severe exacerbations in COPD patients compared to Bevespi and PT009.
AstraZeneca’s stock has rallied 31.3% this year so far, outperforming the industry’s rise of 11.8%.
The press release states that there are almost 100 million people in China affected by COPD. This represent a significant opportunity for the new triple combination therapy.
We remind investors that Glaxo GSK and its partner Innoviva, Inc. INVA also have a triple combination drug (ICS/LAMA/LABA), Trelegy Ellipta, approved for COPD. Theravance Biopharma, Inc. TBPH has an economic interest in Trelegy Ellipta and earns royalties on its sales.
Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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