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Lilly Gets CHMP Nod to Add Heart Indication to Trulicity Label

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Eli Lilly & Company LLY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion to include data from the cardiovascular (CV) outcomes study (REWIND) on the label of its GLP-1 receptor agonist, Trulicity.

REWIND study evaluated the effect of Trulicity 1.5 mg compared to placebo, both added to standard of care on CV events in type II diabetes.

At the American Diabetes Association (ADA) meeting held in June, Lilly presented data from the study, which showed that Trulicity led to a 12% reduction in CV events like CV death, non-fatal myocardial infarction (heart attack) or non-fatal stroke in a broad range of type II diabetes patients with and without established cardiovascular disease.

So far this year, shares of Lilly have risen 2.1% compared with the industry’s increase of 4.6%.



CV disease is common in adults with type II diabetes. With about 50% of deaths in type II diabetics globally resulting from the CV disease, the addition of this data to Trulicity’s label is expected to improve sales of the drug.

Importantly, only 31% of the participants in the REWIND study had established CV disease compared to other CV outcomes studies, which have a much greater percentage of type II diabetes patients already with a heart disease. The statistically significant heart risk reduction shown by Trulicity in the study demonstrates that the drug may be able to cater to a much broader patient population if the data is approved to be included on the label.

In July last year, Trulicity’s label was updated to include data from the AWARD-7 study, which showed that Trulicity was effective and safe in type II diabetes patients with moderate-to-severe chronic kidney disease (CKD).

Trulicity is a key drug in Lilly’s diabetes portfolio. In the second quarter of 2019, Trulicity generated revenues of $1.03 billion, up 32% year over year driven by higher demand in the United States and higher volumes in ex-U.S. markets, which offset the impact of lower realized prices and changes in segment mix. The prices were lower mainly in the United States due to higher contracted rebates and increased coverage gap funding requirements in Medicare Part D.

Trulicity is also facing stiff competition from Novo Nordisk’s NVO Ozempic/semaglutide, launched in 2018. Last week, semaglutide was approved by the FDA in tablet form, which will be marketed by the brand name of Rybelsus. The drug is expected to be launched in the fourth quarter.

In fact, Lilly’s diabetes products are seeing pricing pressure, which creates uncertainty around the franchise’s long-term growth prospects. A number of competitors are entering the diabetes space. For example, with the approval of Merck MRK /Pfizer’s PFE Steglatro and its combinations, competition in the SGLT2 inhibitors class is expected to increase. The class includes Lilly’s key diabetes medicine, Jardiance.

Lilly currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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