AstraZeneca (AZN - Free Report) announced that the FDA has approved its diabetes drug, Bydureon (exenatide extended-release) for injectable suspension, as an adjunctive to basal insulin. The approval allows the use of the drug as add-on therapy to basal insulin for treating type II diabetes (T2D) in patients receiving one or more antidiabetic medicines in addition to diet and exercise and with inadequate glycemic control.
The drug was originally approved in 2012 for the treatment of T2D. In October 2017, the FDA approved the extended release version – Bydureon BCise – in patients with uncontrolled diabetes treated with other oral agents.
AstraZeneca’s shares have returned 1.5% so far this year, against the industry’s decline of 4.3%.
The approval was based on data from the DURATION-7 study, which evaluated Bydureon as an add-on therapy to insulin glargine, with or without metformin. The drug achieved a mean reduction of 0.9% in HbA1c levels compared to 0.2% for placebo, in patients with a mean baseline HbA1c of 8.5%.
Moreover, 32.5% of the patients in the Bydureon arm reached an HbA1c level of less than 7% against 7% of patients in the placebo arm.
However, Bydureon competes with several other diabetes drugs including Johnson & Johnson’s (JNJ - Free Report) Invokamet XR, which has achieved better effectiveness in reducing HbA1c levels in clinical studies.
In a separate press release, AstraZeneca announced that the FDA has granted priority review to the regulatory application seeking approval of anti-CD22 recombinant immunotoxin candidate, moxetumomab pasudotox. A biologics license application (“BLA”) was submitted by the company, seeking approval of the candidate for the treatment of hairy cell leukaemia (“HCL”) in adult patients in second or later-line setting. A decision from the FDA is expected in the third quarter of 2018.
The BLA was submitted based on data from a phase III study, evaluating moxetumomab pasudotox in patients with relapsed or refractory HCL. Data showed that the candidate met the primary endpoint of durable complete response in the study.
In another press release, AstraZeneca along with partner Merck (MRK - Free Report) announced that the European Medicines Agency has accepted the marketing authorization application (“MAA”) for its PARP inhibitor, Lynparza, seeking approval in metastatic breast cancer. The drug is already approved for treating ovarian cancer in EU.
The MAA includes data from the phase OlympiAD study, which evaluated Lynparza against chemotherapy in patients with HER2-negative metastatic breast cancer, harboring germline BRCA mutations.
The drug achieved significant improvement in progression-free survival compared to chemotherapy (7.0 vs 4.2 months). Lynparza also reduced the risk of disease progression or death by 42%.
The MAA is likely to get approval from the EMA as the FDA has already approved Lynparza in a similar indication in January 2018 based on OlympiAD study data.
An approval will certainly boost the prospect of the drug and give it an advantage over other drugs in the PARP inhibitor segment in both the United States and EU. Other PARP inhibitors include Clovis Oncology, Inc.’s Rubraca and TESARO’s Zejula, which are approved only for ovarian cancer. Both the drugs are also being developed for the breast cancer indication.
Zacks Rank
AstraZeneca 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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AstraZeneca (AZN - Free Report) announced that the FDA has approved its diabetes drug, Bydureon (exenatide extended-release) for injectable suspension, as an adjunctive to basal insulin. The approval allows the use of the drug as add-on therapy to basal insulin for treating type II diabetes (T2D) in patients receiving one or more antidiabetic medicines in addition to diet and exercise and with inadequate glycemic control.
The drug was originally approved in 2012 for the treatment of T2D. In October 2017, the FDA approved the extended release version – Bydureon BCise – in patients with uncontrolled diabetes treated with other oral agents.
AstraZeneca’s shares have returned 1.5% so far this year, against the industry’s decline of 4.3%.
The approval was based on data from the DURATION-7 study, which evaluated Bydureon as an add-on therapy to insulin glargine, with or without metformin. The drug achieved a mean reduction of 0.9% in HbA1c levels compared to 0.2% for placebo, in patients with a mean baseline HbA1c of 8.5%.
Moreover, 32.5% of the patients in the Bydureon arm reached an HbA1c level of less than 7% against 7% of patients in the placebo arm.
However, Bydureon competes with several other diabetes drugs including Johnson & Johnson’s (JNJ - Free Report) Invokamet XR, which has achieved better effectiveness in reducing HbA1c levels in clinical studies.
In a separate press release, AstraZeneca announced that the FDA has granted priority review to the regulatory application seeking approval of anti-CD22 recombinant immunotoxin candidate, moxetumomab pasudotox. A biologics license application (“BLA”) was submitted by the company, seeking approval of the candidate for the treatment of hairy cell leukaemia (“HCL”) in adult patients in second or later-line setting. A decision from the FDA is expected in the third quarter of 2018.
The BLA was submitted based on data from a phase III study, evaluating moxetumomab pasudotox in patients with relapsed or refractory HCL. Data showed that the candidate met the primary endpoint of durable complete response in the study.
In another press release, AstraZeneca along with partner Merck (MRK - Free Report) announced that the European Medicines Agency has accepted the marketing authorization application (“MAA”) for its PARP inhibitor, Lynparza, seeking approval in metastatic breast cancer. The drug is already approved for treating ovarian cancer in EU.
The MAA includes data from the phase OlympiAD study, which evaluated Lynparza against chemotherapy in patients with HER2-negative metastatic breast cancer, harboring germline BRCA mutations.
The drug achieved significant improvement in progression-free survival compared to chemotherapy (7.0 vs 4.2 months). Lynparza also reduced the risk of disease progression or death by 42%.
The MAA is likely to get approval from the EMA as the FDA has already approved Lynparza in a similar indication in January 2018 based on OlympiAD study data.
An approval will certainly boost the prospect of the drug and give it an advantage over other drugs in the PARP inhibitor segment in both the United States and EU. Other PARP inhibitors include Clovis Oncology, Inc.’s Rubraca and TESARO’s Zejula, which are approved only for ovarian cancer. Both the drugs are also being developed for the breast cancer indication.
Zacks Rank
AstraZeneca carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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