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AstraZeneca's Bydureon Fails to Reduce Cardiovascular Risk
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AstraZeneca plc (AZN - Free Report) announced top-line results from the EXSCEL study evaluating the cardiovascular (CV) safety profile of its type II diabetes drug Bydureon. Though the study met the primary safety objective in the study, Bydureon, a human glucagon-like peptide-1 (GLP-1) analogue, failed to reduce the risk of major adverse cardiovascular events.
The Phase IIIb/IV cardiovascular outcomes study was carried out in more than 1400 patients from 35 countries with type-II diabetes with or without additional cardiovascular (CV) risk factors or prior CV events. The study compared the effect of once-weekly Bydureon (exenatide extended-release) versus placebo on reducing the risk of MACE in such patients.
MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke. Data from the study showed that Bydureon did not increase the risk of MACE and showed a consistent safety profile. Meanwhile, fewer CV events were observed in the Bydureon arm. However, the efficacy objective of a superior reduction in CV risk did not reach statistical significance.
AstraZeneca’s shares are up 29.3% year to date, comparing favorably with an increase of 13.5% witnessed by the Zacks classified Large-Cap Pharma industry.
Coming back to the latest news, EXSCEL was jointly run by two academic research organizations. Full data from the study will be presented at the annual meeting of European Association for the Study of Diabetes (EASD) to be held in September.
With death from cardiovascular disease being significantly higher in adults with diabetes compared to those without diabetes, the addition of positive cardiovascular outcomes data on labels of diabetes drugs can help drive sales. While some diabetes drugs have demonstrated cardiovascular benefit in studies, some others have not.
Novo Nordisk AS’ (NVO - Free Report) key diabetes drug Victoza, also a GLP-1 analogue, has in the past, shown a statistically significant reduction of cardiovascular risk in the LEADER cardiovascular outcomes study in type II diabetes patients. The application to include the LEADER data on Victoza’s label is under review in the U.S. and EU.
Eli Lilly & Company (LLY - Free Report) and Boehringer Ingelheim received FDA approval last year to include CV risk reduction data from the EMPA-REG OUTCOME study on the label of their SGLT-2 inhibitor, Jardiance. The updated label including the cardiovascular indication was launched in Jan 2017. The European Commission also approved the Jardiance label update for the cardiovascular indication in 2016.
However, last month, Merck & Co., Inc. (MRK - Free Report) was denied approval by the FDA to include cardiovascular outcomes data from the TECOS study on the labels of its DPP-IV inhibitor Januvia (sitagliptin) and other medicines containing Januvia.
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AstraZeneca's Bydureon Fails to Reduce Cardiovascular Risk
AstraZeneca plc (AZN - Free Report) announced top-line results from the EXSCEL study evaluating the cardiovascular (CV) safety profile of its type II diabetes drug Bydureon. Though the study met the primary safety objective in the study, Bydureon, a human glucagon-like peptide-1 (GLP-1) analogue, failed to reduce the risk of major adverse cardiovascular events.
The Phase IIIb/IV cardiovascular outcomes study was carried out in more than 1400 patients from 35 countries with type-II diabetes with or without additional cardiovascular (CV) risk factors or prior CV events. The study compared the effect of once-weekly Bydureon (exenatide extended-release) versus placebo on reducing the risk of MACE in such patients.
MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke. Data from the study showed that Bydureon did not increase the risk of MACE and showed a consistent safety profile. Meanwhile, fewer CV events were observed in the Bydureon arm. However, the efficacy objective of a superior reduction in CV risk did not reach statistical significance.
AstraZeneca’s shares are up 29.3% year to date, comparing favorably with an increase of 13.5% witnessed by the Zacks classified Large-Cap Pharma industry.
Coming back to the latest news, EXSCEL was jointly run by two academic research organizations. Full data from the study will be presented at the annual meeting of European Association for the Study of Diabetes (EASD) to be held in September.
With death from cardiovascular disease being significantly higher in adults with diabetes compared to those without diabetes, the addition of positive cardiovascular outcomes data on labels of diabetes drugs can help drive sales. While some diabetes drugs have demonstrated cardiovascular benefit in studies, some others have not.
Novo Nordisk AS’ (NVO - Free Report) key diabetes drug Victoza, also a GLP-1 analogue, has in the past, shown a statistically significant reduction of cardiovascular risk in the LEADER cardiovascular outcomes study in type II diabetes patients. The application to include the LEADER data on Victoza’s label is under review in the U.S. and EU.
Eli Lilly & Company (LLY - Free Report) and Boehringer Ingelheim received FDA approval last year to include CV risk reduction data from the EMPA-REG OUTCOME study on the label of their SGLT-2 inhibitor, Jardiance. The updated label including the cardiovascular indication was launched in Jan 2017. The European Commission also approved the Jardiance label update for the cardiovascular indication in 2016.
However, last month, Merck & Co., Inc. (MRK - Free Report) was denied approval by the FDA to include cardiovascular outcomes data from the TECOS study on the labels of its DPP-IV inhibitor Januvia (sitagliptin) and other medicines containing Januvia.
Zacks Rank & Stocks to Consider
AstraZeneca currently has 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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Zacks has just released a Special Report on the booming investment opportunities of legal marijuana. Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look. See the pot trades we're targeting>>