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AstraZeneca’s Forxiga Label Expansion Filing Accepted in EU


AstraZeneca AZN announced that the European Medicines Agency has accepted the Marketing Authorization Variation (MAV) for the label expansion of Forxiga (dapagliflozin).

Forxiga, a selective SGLT-2 inhibitor, is presently marketed both as a monotherapy as well as a combination therapy to improve glycaemic controlin adult patients with type-2 diabetes (T2D).

With the MAV, AstraZeneca is seeking to get Forxiga approved as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The submission to EMA was based on phase III data from the DEPICT study which showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, led to significant and clinically-relevant reductions from baseline in blood sugar levels (HbA1c), weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5 mg and 10 mg doses.

Over a year, AstraZeneca’s shares have rallied 14.4%, outperforming the industry’s gain of 8.8%.

We remind investors that in December 2017, Merck MRK and Pfizer Inc.’s PFE investigational oral SGLT-2 inhibitor, Steglatro (ertugliflozin) tablets, and Steglujan (ertugliflozin + sitagliptin) were approved by the FDA as an adjunct to diet and exercise for improving glycemic control in patients with type 2 diabetes mellitus.

Apart from these two drugs, the FDA also approved Segluromet (ertugliflozin + metformin) for the same indication in patients already treated with Steglatro or Glucophage (metformin) with inadequately controlled type 2 diabetes mellitus and patients who are already treated with combination of ertugliflozin and metformin.

Zacks Rank and Stock to Consider

AstraZeneca carries a Zacks Rank #4 (Sell). Another better-ranked stock from the same space is Regeneron REGN carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up from $17.13 to $18.65 and from $20.37 to $21.56 for 2018 and 2019 respectively in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.

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