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AstraZeneca's (AZN) Triple Combo COPD Therapy Gets EU Nod
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AstraZeneca plc (AZN - Free Report) announced that the European Commission has granted approval to its triple combination therapy, Trixeo Aerosphere as maintenance treatment for chronic obstructive pulmonary disease (COPD). The triple combination therapy is already approved by the trade name of Breztri Aerosphere in Japan, China and the United States.
Trixeo Aerosphere/Breztri Aerosphere is a combination of budesonide, an inhaled corticosteroid (ICS), glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-agonists (LABA) therapy.
The approval was based on positive data from the phase III ETHOS study, which showed that Trixeo Aerosphere/Breztri Aerosphere led to statistically significant reduction in the rate of moderate or severe exacerbations compared to dual combination therapies — Bevespi Aerosphere and PT009 — in COPD.
This year so far, AstraZeneca’s shares have risen 0.4% compared with an increase of 4.2% for the industry.
In a separate press release, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending conditional marketing authorization of its antibody drug conjugate (ADC), trastuzumab deruxtecan in the European Union for third-line HER2-positive metastatic breast cancer.
Trastuzumab deruxtecan is already approved for the same indication in the United States and marketed by the brand name of Enhertu. Meanwhile, regulatory applications seeking approval of Enhertu for HER2+, metastatic gastric cancer are under priority review in the United States with an FDA decision expected in the first quarter of 2021. AstraZeneca acquired the joint development and commercialization rights to trastuzumab deruxtecan from Daiichi Sankyo in 2019.
The CHMP also recommended marketing authorization for a new four-week, fixed-dose regimen of AstraZeneca’s PD-L1 inhibitor, Imfinzi in the approved indication of unresectable non-small cell lung cancer (NSCLC) after chemoradiation therapy in EU.
The new dosing regimen of Imfinzi was approved in the United States in November for the approved indications of stage III NSCLC after chemoradiation therapy and previously treated advanced bladder cancer.
Imfinzi is presently administered as a weight-based dosing of 10mg/kg every two weeks. The four-week, fixed-dose regimen (1500 mg) will reduce patients’ medical visits by half.
Some other PD-L1 inhibitors available in the market are Merck’s (MRK - Free Report) Keytruda, Bristol-Myers’ (BMY - Free Report) Opdivo and Pfizer’s (PFE - Free Report) Bavencio.
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AstraZeneca's (AZN) Triple Combo COPD Therapy Gets EU Nod
AstraZeneca plc (AZN - Free Report) announced that the European Commission has granted approval to its triple combination therapy, Trixeo Aerosphere as maintenance treatment for chronic obstructive pulmonary disease (COPD). The triple combination therapy is already approved by the trade name of Breztri Aerosphere in Japan, China and the United States.
Trixeo Aerosphere/Breztri Aerosphere is a combination of budesonide, an inhaled corticosteroid (ICS), glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-agonists (LABA) therapy.
The approval was based on positive data from the phase III ETHOS study, which showed that Trixeo Aerosphere/Breztri Aerosphere led to statistically significant reduction in the rate of moderate or severe exacerbations compared to dual combination therapies — Bevespi Aerosphere and PT009 — in COPD.
This year so far, AstraZeneca’s shares have risen 0.4% compared with an increase of 4.2% for the industry.
In a separate press release, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending conditional marketing authorization of its antibody drug conjugate (ADC), trastuzumab deruxtecan in the European Union for third-line HER2-positive metastatic breast cancer.
Trastuzumab deruxtecan is already approved for the same indication in the United States and marketed by the brand name of Enhertu. Meanwhile, regulatory applications seeking approval of Enhertu for HER2+, metastatic gastric cancer are under priority review in the United States with an FDA decision expected in the first quarter of 2021. AstraZeneca acquired the joint development and commercialization rights to trastuzumab deruxtecan from Daiichi Sankyo in 2019.
The CHMP also recommended marketing authorization for a new four-week, fixed-dose regimen of AstraZeneca’s PD-L1 inhibitor, Imfinzi in the approved indication of unresectable non-small cell lung cancer (NSCLC) after chemoradiation therapy in EU.
The new dosing regimen of Imfinzi was approved in the United States in November for the approved indications of stage III NSCLC after chemoradiation therapy and previously treated advanced bladder cancer.
Imfinzi is presently administered as a weight-based dosing of 10mg/kg every two weeks. The four-week, fixed-dose regimen (1500 mg) will reduce patients’ medical visits by half.
Some other PD-L1 inhibitors available in the market are Merck’s (MRK - Free Report) Keytruda, Bristol-Myers’ (BMY - Free Report) Opdivo and Pfizer’s (PFE - Free Report) Bavencio.
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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Although marijuana stocks did better as the pandemic took hold than the market as a whole, they’ve been pushed down. This is exactly the right time to get in on selected strong companies at a fraction of their value before COVID struck. Zacks’ Special Report, Marijuana Moneymakers, reveals 10 exciting tickers for urgent consideration.
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