AstraZeneca PLC (AZN - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending the marketing approval for Qtrilmet modified-release tablets to treat type-II diabetes (T2D). Qtrilmet is a combination of AstraZeneca's diabetes drugs Forxiga (dapagliflozin) and Onglyza (saxagliptin) plus hydrochloride.
Qtrilmet is marketed as Qternmet XR in the United States after the FDA approved it in May 2019.
The CHMP opinion was based on data from the five phase III studies that evaluated the combination of Farxiga + Onglyza on a background of metformin in patients with inadequately-controlled T2D. The primary endpoint of these studies was to see the mean change from baseline in average blood glucose levels at week 24 or week 52 of the regimen.
Notably, the combo of Farxiga and Onglyza plus metformin was superior in reducing the blood glucose level in all these studies. The three-drug combo was also better than other combination regimens, such as Farxiga + metformin, Onglyza + metformin or Sanofi's (SNY - Free Report) Amaryl (glimepiride) plus metformin.
Shares of AstraZeneca have rallied 17.3% so far this year, outperforming the industry's increase of 0.5%.
We remind investors that Forxiga was approved for type I diabetes indication in Europe this March and is under review in the United States for the same indication. Forxiga is known by the name Farxiga in the United States. Several studies on Farxiga to evaluate its effect on renal outcome and cardiovascular mortality in patients suffering chronic kidney disease with or without T2D are currently underway.
Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales of $726 million in the first half of 2019, representing 19% growth at constant exchange rate. Onglyza generated sales of $269 million in the first half of 2019, reflecting an increase of 10% at constant exchange rate.
Notably, diabetes is one of AstraZeneca's key focus areas, heavily crowded with a number of products present in the market. The diabetes franchise is facing an increased pricing pressure too. The company's Farxiga/Forxiga belongs to the same class (SGLT2) as Johnson & Johnson's (JNJ - Free Report) Invokana and Lilly's (LLY - Free Report) Jardiance.
AstraZeneca currently carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
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