AstraZeneca PLC AZN announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval for its SGLT2 inhibitor, Forxiga (dapagliflozin), for a new indication. The company is looking to get Forxiga approved for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adult patients with and without type-II diabetes (T2D).
The positive CHMP opinion was based on favorable results from the phase III DAPA-HF study, which evaluated Forxiga for the given indication.
Per the company, Forxiga is the first SGLT2 inhibitor that demonstrated a statistically significant reduction in the risk of cardiovascular (CV) death or worsening of heart failure (HF) events as compared to placebo. If approved, the drug will become the first SGLT2 inhibitor to address HFrEF, regardless of T2D, in Europe.
The FDA approved Farxiga (brand name of Forxiga in the United States) for the same indication in May 2020.
Shares of AstraZeneca have gained 5.2% so far this year against the industry’s decline of 1.2%.
Notably, several other outcomes studies are being conducted on Farxiga for heart failure indications. The drug is also being studied in the DELIVER study to evaluate its effect on patients with HF with preserved ejection fraction (HFpEF) and the DAPA-MI study for evaluating patients without T2D following an acute myocardial infarction (MI) or heart attack.
Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales worth $848 million in the first six months of 2020, representing 21% growth at constant exchange rates. Label expansion of the drug for additional indications should drive sales further.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s JNJ Invokana and Lilly’s LLY Jardiance.
In a separate press release, AstraZeneca announced that the CHMP has also rendered a positive opinion, recommending marketing authorization to its triple combination therapy, Trixeo Aerosphere, as maintenance treatment for moderate to severe chronic obstructive pulmonary disease (“COPD”). Trixeo Aerosphere is a combination of budesonide, glycopyrronium and formoterol fumarate. The therapy had been approved in the United States, China and Japan with the trade name of Breztri Aerosphere for a similar indication.
We note that budesonide is an ICS, glycopyrronium is a long-acting muscarinic antagonist (“LAMA”) and formoterol fumarate is a long-acting beta-agonists (“LABA”) therapy. Breztri Aerosphere can be delivered using AstraZeneca’s Aerosphere Delivery Technology.
The positive CHMP opinion was based on data from the phase III ETHOS and KRONOS studies. Data from the studies showed that Trixeo Aerosphere was generally well tolerated and the safety profile was similar with the dual comparators.
Zacks Rank & A Key Pick
AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the drug/biotech sector is Vertex Pharmaceuticals Incorporated VRTX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex’s earnings estimates have been revised 1.5% upward for 2020 and 2.3% for 2021 over the past 60 days. The stock has inched up 0.7% year to date.
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