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AstraZeneca's (AZN) Bydureon Gets FDA Nod for Expanded Use


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AstraZeneca AZN 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 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 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 CLVS Rubraca and TESARO's Zejula, which are approved only for ovarian cancer. Both the drugs are also being developed for the breast cancer indication.

AstraZeneca PLC Price

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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 PLC (AZN): Free Stock Analysis Report

Johnson & Johnson (JNJ): Free Stock Analysis Report

Merck & Co., Inc. (MRK): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.



This article appears in: Investing , Business , Stocks
Referenced Symbols: AZN , JNJ , MRK , CLVS



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