FDA lets Lilly cite Jardiance heart data, shares jump

[December 05, 2016]  By Ransdell Pierson and Toni Clarke

(Reuters) - U.S regulators said on Friday they would allow Eli Lilly and Co to state that its diabetes drug Jardiance reduces risk of death from heart problems, lifting company shares almost 3 percent and potentially giving a strong boost to the drug's future sales.

Jardiance, a once-daily pill also known as empagliflozin, was approved by the FDA in 2014 to help lower blood sugar in patients with type 2 diabetes. It generated global sales of $48 million in the third quarter.

Lilly sells the drug in partnership with privately held German drugmaker Boehringer Ingelheim.

At the time of approval the FDA asked that a separate trial be conducted to show the drug did not increase the risk of cardiovascular problems.

The study instead unexpectedly showed Jardiance slashed deaths by 32 percent in patients with type 2 diabetes at risk of heart attack and stroke, when added to standard diabetes medications.

It was the first time any diabetes drug was shown to reduce risk of cardiovascular death. Moreover, patients taking Jardiance had a 35 percent lower rate of hospitalization for heart failure. That information can now be included on the drug's label.

Jardiance belongs to a new family of treatments called SGLT2 inhibitors that include Johnson & Johnson's $1.3 billion-a-year Invokana and AstraZeneca Plc's Farxiga.

With the strong heart-protection data now on Jardiance’s label, Lilly’s sale force can freely advertise it with doctors and medical professionals, Evercore ISI analyst John Scotti said in a research note.

“This arguably bodes well for the growth of the Jardiance franchise and for the SGLT-2 class as a whole,” Scotti said.

He said Wall Street expects Jardiance sales to reach about $4 billion in 2025, with about $1.7 billion going to Lilly.

The risk of death from heart disease is 70 percent higher in diabetics compared to those without diabetes, according to the U.S. Centers for Disease Control and Prevention. (http://bit.ly/2gP4Bpd)

Lilly shares were up 2.9 percent to $67.86 in late-afternoon trading on the New York Stock Exchange.

About 26 million Americans have type 2 diabetes, the most common form of the disease which is linked to obesity, according to federal data for 2014.

(Reporting by Akankshita Mukhopadhyay and Ransdell Pierson; Editing by Shounak Dasgupta and Andrew Hay)

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