We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
AstraZeneca's Bevespi Unimpressive in Phase III COPD Study
Read MoreHide Full Article
AstraZeneca (AZN - Free Report) announced disappointing data from a phase IIIb study evaluating Bevespi Aerosphere for treating moderate to very severe chronic obstructive pulmonary disease (“COPD”). The study compared the drug to GlaxoSmithKline’s (GSK - Free Report) Anoro Ellipta (umeclidinium/vilanterol).
Data from the study showed that Bevespi Aerosphere is not inferior to Anoro Ellipta on peak forced expiratory volume in one second (FEV1), a measure of lung function. However, it failed to show superiority over Anoro Ellipta. Moreover, Bevespi Aerosphere failed to demonstrate non-inferiority over Anoro Ellipta in trough FEV1.
The 24-week phase IIIb AERISTO study evaluated Bevespi Aerosphere in patients with COPD for non-inferiority and superiority in peak FEV1 and non-inferiority alone in trough FEV1 compared to Anoro Ellipta. Patients were administered either two inhalations twice a day of Bevespi Aerosphere or one inhalation once a day of Anoro Ellipta.
Peak FEV1 is the maximum amount of air a person can forcefully exhale in one second after taking a deep breath following the administration of an inhaler. Trough FEV1 measures the same before drug administration or after a day of administration.
The press release also stated that data from the study were “inconsistent with previous data”. The company is conducting a detailed analysis to understand the inconsistency and a detailed report will be presented at a future medical meeting.
Bevespi Aerosphere is a combination of a LAMA (glycopyrronium) and a LABA (formoterol fumarate) drug. The drug is marketed in the United States and Canada as long-term maintenance treatment of airflow obstruction in patients with COPD. The drug is not yet available in Europe, however, a regulatory application is under review in Europe and a decision is expected later this year.
Shares of AstraZeneca have gained 9.8% year to date versus the industry’s decline of 5.1%.
The drug, launched in the first quarter of 2017, generated sales of $13 million in the first half of 2018. The failure of the drug in the study may unfavorably impact the prospects of the drug.
Moreover, the already crowded respiratory therapeutic area is getting more competitive with new and better drugs getting approval. Apart from the above two drugs, Novartis’ (NVS - Free Report) Utibron Neohaler ,also a two-drug combination, is approved for treating COPD. Meanwhile, Glaxo and its partner Innoviva, Inc. (INVA - Free Report) also have a triple combination drug (ICS/LAMA/LABA), Trelegy Ellipta, in their product portfolio. AstraZeneca is also developing its triple combination candidate, PT010, for treating COPD.
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Image: Bigstock
AstraZeneca's Bevespi Unimpressive in Phase III COPD Study
AstraZeneca (AZN - Free Report) announced disappointing data from a phase IIIb study evaluating Bevespi Aerosphere for treating moderate to very severe chronic obstructive pulmonary disease (“COPD”). The study compared the drug to GlaxoSmithKline’s (GSK - Free Report) Anoro Ellipta (umeclidinium/vilanterol).
Data from the study showed that Bevespi Aerosphere is not inferior to Anoro Ellipta on peak forced expiratory volume in one second (FEV1), a measure of lung function. However, it failed to show superiority over Anoro Ellipta. Moreover, Bevespi Aerosphere failed to demonstrate non-inferiority over Anoro Ellipta in trough FEV1.
The 24-week phase IIIb AERISTO study evaluated Bevespi Aerosphere in patients with COPD for non-inferiority and superiority in peak FEV1 and non-inferiority alone in trough FEV1 compared to Anoro Ellipta. Patients were administered either two inhalations twice a day of Bevespi Aerosphere or one inhalation once a day of Anoro Ellipta.
Peak FEV1 is the maximum amount of air a person can forcefully exhale in one second after taking a deep breath following the administration of an inhaler. Trough FEV1 measures the same before drug administration or after a day of administration.
The press release also stated that data from the study were “inconsistent with previous data”. The company is conducting a detailed analysis to understand the inconsistency and a detailed report will be presented at a future medical meeting.
Bevespi Aerosphere is a combination of a LAMA (glycopyrronium) and a LABA (formoterol fumarate) drug. The drug is marketed in the United States and Canada as long-term maintenance treatment of airflow obstruction in patients with COPD. The drug is not yet available in Europe, however, a regulatory application is under review in Europe and a decision is expected later this year.
Shares of AstraZeneca have gained 9.8% year to date versus the industry’s decline of 5.1%.
The drug, launched in the first quarter of 2017, generated sales of $13 million in the first half of 2018. The failure of the drug in the study may unfavorably impact the prospects of the drug.
Moreover, the already crowded respiratory therapeutic area is getting more competitive with new and better drugs getting approval. Apart from the above two drugs, Novartis’ (NVS - Free Report) Utibron Neohaler ,also a two-drug combination, is approved for treating COPD. Meanwhile, Glaxo and its partner Innoviva, Inc. (INVA - Free Report) also have a triple combination drug (ICS/LAMA/LABA), Trelegy Ellipta, in their product portfolio. AstraZeneca is also developing its triple combination candidate, PT010, for treating COPD.
AstraZeneca PLC Price
AstraZeneca PLC Price | AstraZeneca PLC Quote
Zacks Rank
AstraZeneca currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>