AstraZeneca plc. AZN announced that its investigational triple combination therapy, PT010 has been approved by the Japanese regulatory authority to relieve symptoms of chronic obstructive pulmonary disease (COPD).
PT010 is a combination of budesonide, an ICS with glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-agonists (LABA) therapy. PT010 can be delivered using AstraZeneca’s Aerosphere Delivery Technology.
With the approval, PT010, to be marketed by the trade name of Breztri Aerospher, will be the only triple-combination therapy in a pressurized metered-dose inhaler device to be approved in Japan. This approval marks the first global regulatory approval for Breztri Aerospher while the candidate is under review in the United States and EU.
The approval is based on positive data from the KRONOS study, which compared PT010 to dual combination therapies — Bevespi Aerosphere, Symbicort Turbuhaler, 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 Japan, versus the dual combination therapies.
We remind investors that Glaxo GSK also markets a once-daily, single inhaler triple combination therapy Trelegy Ellipta, for COPD. Trelegy Ellipta is a combination of fluticasone furoate — an ICS, umeclidinium — a LAMA and vilanterol — a LABA therapy. Trelegy Ellipta is delivered in Glaxo’s Ellipta dry powder inhaler. Theravance Biopharma, Inc. TBPH has an economic interest in Trelegy Ellipta and earns royalties on its sales.
Along with the approval for the triple combo inhaler, Japan’s Ministry of Health, Labour and Welfare also granted approval to Bevespi Aerosphere, AstraZeneca’s fixed-dose dual (LABA/LAMA) inhaler that is delivered in a pressurized metered-dose inhaler. Bevespi Aerosphere is already approved in the United States, Europe Canada and Australia as a dual bronchodilator for the long-term maintenance treatment of COPD.
AstraZeneca’s stock has rallied 9.7% this year so far, outperforming the industry’s rise of 3.3%.
AstraZeneca and partner Merck MRK also gained approval in Japan for their PARP inhibitor Lynparza for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer. It was approved in the United States for the indication in late 2018 while the same in Europe came earlier this week.
With the latest approval, Lynparza can now be used in Japan as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated advanced ovarian cancer as detected by an approved companion diagnostic test.
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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