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AstraZeneca (AZN) Gets EU Nod for New Formulation of Bydureon

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AstraZeneca PLC (AZN - Free Report) announced that the European Commission has granted approval to Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of its GLP-1 receptor agonist Bydureon in an improved once-weekly, single-dose pre-filled BCise device for treating patients with type-II diabetes (T2D).

The nod was expected as earlier in June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion, recommending marketing approval for the new device. Bydureon BCise was approved in the United States in October last year.

The approval of this new formulation of once-weekly Bydureon will allow the use of the drug as an add-on therapy to basal insulin for treating type II diabetes in patients receiving one or more antidiabetic medicines in addition to diet and exercise and with inadequate glycemic control.

Shares of AstraZeneca have returned 11.9% so far this year, outperforming the industry’s increase of 5%.

The approval was based on data from the DURATION-NEO-1 and NEO-2 studies, which showed that once-weekly Bydureon BCise led to a reduction of 1.4% in blood sugar levels compared with 1% for twice-daily dose of Byetta (exenatide) injection at 28 weeks. Moreover, the drug achieved a mean weight reduction of 1.5 kg as a monotherapy compared with 1.9 kg pertaining to oral antidiabetic medicines.

Bydureon recorded sales of $155 million in second-quarter 2018. The expanded indication will definitely boost sales of the drug in the future quarters and will help AstraZeneca drive its revenues.

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. Lilly’s (LLY - Free Report) Trulicity is another GLP-1 receptor agonist available in the market approved for a once weekly dosing regimen.

AstraZeneca PLC Price and Consensus

AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma sector is Illumina, Inc. (ILMN - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings estimates have been raised 12.1% for 2018 and 10% for 2019 over the past 60 days. The stock has soared 60.4% so far this year.

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