AstraZeneca plc. (AZN - Free Report) announced that the Japanese regulatory authority has granted marketing approval to its SGLT2 inhibitor Forxiga for a new indication — as an oral adjunct treatment to insulin in adults with type-Idiabetes.
With this approval from the Japanese Ministry of Health, Labour and Welfare (MHLW), Forxigacan now be prescribed to type-Idiabetespatients whose glucose levels are not adequately controlled with insulin alone. The approval is based on data from the phase III DEPICT study and a special study conducted in Japanese patients.
Data from the study showed that both the 5mg and 10mg doses of Forxiga led to 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 weeks.
Please note that Forxiga was approved for type I diabetes in Europe last week and is under review in the United States for the same indication with a decision expected in the second half of 2019. Forxiga is known by the name of Farxiga in United States. Farxiga/Forxiga 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-II diabetes.
Talking about type-I diabetes drugs, the FDA recently issued a complete response letter to Lexicon Pharmaceuticals, Inc.’s (LXRX - Free Report) new drug application seeking approval of its lead pipeline candidate, Zynquista (sotagliflozin). Zynquista is a dual SGLT1 and SGLT2 inhibitor evaluated in combination with insulin for type-I diabetes in adult patients. Lexicon is developing the candidate in collaboration with Sanofi (SNY - Free Report) .
AstraZeneca’s stock has rallied 12.3% this year so far, outperforming the industry’s rise of 4.9%.
Farxiga/Forxiga, a key driver of AstraZeneca’s top line, recorded sales of almost $1.4 billion in 2018, representing growth of 30%. Farxiga, one of the many successful new drugs in AstraZeneca’s portfolio,enjoys volume market share leadership globally.The approval for the type I diabetes indication expands the drugs’ eligible patient population, which should improve sales in the future quarters.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s(JNJ - Free Report) Invokana and Lilly’s Jardiance, Synjardy (a fixed dose combination of Jardiance and metformin) and Glyxambi(a fixed dose combination of Jardiance and Tradjenta).
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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