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Lilly's Heart Drug Snags Fast Track Designation; Type 2 Diabetes Drug Found Effective At Higher Doses

Lilly's Heart Drug Snags Fast Track Designation; Type 2 Diabetes Drug Found Effective At Higher Doses

Large-cap pharma Eli Lilly And Co (NYSE: LLY) has pulled back significantly from its late-March intra-day high of $132.13.

The company issued updates on heart failure and diabetes drugs Wednesday. 

Fast-Track Designation For Heart Failure Drug 

Lilly said the FDA granted the Fast Track designation to empagliflozin, which is being evaluated for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.

Fast Track designation is accorded to develop new therapies that fill an unmet medical need for serious conditions to facilitate expeditious availability of new treatment options.

The designation vests the advantages of more frequent meetings and correspondence with the FDA to discuss drug development; the scope for accelerated approval or priority review if requisite criteria are met; and eligibility for a rolling review.

Empagliflozin, which goes by the trade name Jardiance, is co-developed by Lilly and the German pharma company Boehringer Ingelheim.

The drug has already been approved as once-daily tablet for two indications: Type 2 diabetes and the reduction of cardiovascular death in adults with Type 2 diabetes.

Heart failure contributes to one in nine deaths and is the leading cause of hospitalization in the U.S., but has limited treatment options, the companies said in a press release. 

Empagliflozin is being evaluated in two Phase 3 studies dubbed EMPEROR.

Diabetes Drug Aces Late-stage Trial 

Lilly said a trial that evaluated higher investigational doses of Trulicity met its primary endpoint of superiority, significantly reducing A1C from baseline in people with Type 2 diabetes compared to once-weekly Trulicity 1.5mg after 36 weeks.

Trulicity was first approved as once-daily subcutaneous injection along with diet and exercise by the FDA for Type 2 diabetes in 2014.

The higher dose was tested in a Phase 3 study dubbed AWARD-11, which evaluated the safety and efficacy of 3mg and 4mg doses in 1,842 participants with Type 2 diabetes.

Lilly shares were down 2.7% at $112.25 at the time of publication Wednesday. 

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Photo by Dustin Blitchok. 

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