- Topline clinical data released Tuesday indicate that significantly fewer patients died from a cardiovascular event or experienced worsening heart failure when taking Farxiga, a Type 2 diabetes drug developed by AstraZeneca, as opposed to placebo.
- The Phase 3 DAPA-HF trial enrolled nearly 4,750 patients with a history of heart failure and reduced ejection fraction, meaning the left ventricles in their hearts pump out less than normal amounts of blood. Patients with and without Type 2 diabetes were allowed to participate.
- Full results from DAPA-HF should be presented at an upcoming medical meeting. In the meantime, Farxiga stands as the only drug in its class of SGLT2 inhibitors to demonstrate such an effect on this patient population. Other members of the class are Johnson & Johnson's Invokana, Merck & Co.'s Steglatro, and Eli Lilly and Boehringer Ingelheim's Jardiance.
The leading cause of death in the U.S., cardiovascular disease, is a prime target for drugmakers.
The American College of Cardiology found that, between 2013 and 2016, roughly 6.2 million American adults experienced heart failure. Around half of the newly hospitalized patients had reduced ejection fraction, or rEF, while the other half had a different type of heart failure known as preserved ejection fraction, or pEF.
AstraZeneca is targeting both groups though a late-stage Farxiga (dapagliflozin) program, with DAPA-HF the first of three heart failure studies to readout.
Cowen & Co. analyst Steve Scala called DAPA-HF a critical study for SGLT2 inhibitors. By enrolling non-diabetic patients, the trial may position the class to become heart failure treatments "as opposed to just diabetes drugs."
Scala highlighted two other studies evaluating Jardiance (empagliflozin) in either rEF or pEF patients as important near-term catalysts for the class.
SGLT2 inhibitors already clenched victories across a few large cardiovascular outcomes studies. The EMPA-REG trial of Jardiance, for instance, found it lowered the risk of cardiovascular events 14% and death 38%. Those results led regulators to amend the drug's label to include reduced cardiovascular death in adults with Type 2 diabetes.
Still, Scala noted that "results of these studies have generated great enthusiasm in the heart failure community" regarding the use of SGLT2 inhibitors.
That may be particularly important for diabetes drugmakers, given the competitive and payer challenges weighing on the therapeutic area as well as the increasing government scrutiny over insulin prices.
Sales of Farxiga and Jardiance totaled $1.4 billion and $2.3 billion respectively in 2018 — up 30% and 47%& year over year. Invokana sales of $881 million were down 21% year over year.
AstraZeneca shares were about 1% higher at market's open Tuesday, trading at $44.85 apiece. The shares have climbed more than 17% since the start of the year.