AstraZeneca plc AZN announced that the European Commission (EC) has approved a label expansion of its diabetes drug, Forxiga (dapagliflozin).
Forxiga has been approved for the treatment of type-1 diabetes (T1D) as an adjunct to insulin in patients with a BMI ≥ 27 kg/m2 when insulin alone does not provide adequate glycemic control despite optimal insulin therapy.
The approval was based on encouraging data from the phase III DEPICT study for Forxiga in T1D. Short-term (24 week) and long-term (52 week) data from DEPICT-1 along with short-term data from DEPICT-2 showed that Forxiga 5mg daily resulted in significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks.
We remind investors that Forxiga, a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2), is already approved as both monotherapy and combination therapy to improve glycemic control, with additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with type-2 diabetes (T2D).
In the past year, AstraZeneca’s shares have rallied 26.7%, outperforming the industry’s growth of 17.2%.
Newer drugs like Brilinta (cardiovascular), Lynparza (ovarian cancer), Farxiga/Forxiga and Tagrisso (lung cancer) are driving top-line growth.
Sales of Forxiga came in at $1.3 billion in 2018. Label expansion of the drug will further boost the top line.
The drug is also under review in the United States and Japan for use as an adjunct treatment to insulin in adults with T1D. A decision in the United States is expected in the second half of 2019 and Japan in the first half.
We expect investors to now focus on the regulatory application in the United States. The FDA recently issued a complete response letter (“CRL”) to Lexicon Pharmaceuticals, Inc. LXRX’s new drug application (“NDA”) seeking approval of its lead pipeline candidate, Zynquista (sotagliflozin). Zynquista is a dual SGLT1 and SGLT2 inhibitor evaluated in combination with insulin for the treatment of T1D in adult patients. Lexicon is developing the candidate in collaboration with Sanofi SNY.
Zacks Rank & A Key Pick
AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Celgene Corporation CELG, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings estimates have been revised 3.7% upward for 2019 over the past 60 days. The stock has rallied 37.5% so far this year.
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