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FDA approves Lilly, Boehringer diabetes drug

August 1, 2014

Federal regulators have approved a new treatment from Indianapolis-based drugmaker Eli Lilly and Co. and its German co-partner, Boehringer Ingelheim, for the most common form of diabetes .

The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition with diet and exercise.

The drug is designed to be taken once a day to reduce a patient's blood sugar levels by blocking glucose reabsorption in the kidneys and removing excess glucose through urine. Unlike other diabetes treatments, it does not depend on a patient's insulin levels to be effective.

European Union regulators had already approved the drug, also labeled empagliflozin, in May.

Lilly is expected to garner $518 million in annual sales from Jardiance by 2019, according to the average of five analyst estimates compiled by Bloomberg earlier this year.

Earlier this year, Lilly and Boehringer said the FDA didn't approve the drug because of concerns about the Boehringer factory in Germany where it will be made. But a Lilly spokeswoman said Friday those concerns have been resolved.

Boehringer developed the drug, and Lilly will help co-promote it.

Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can cause early death or serious complications like blindness, a stroke, kidney disease or heart disease when blood sugar climbs too high and damages organs and blood vessels.

Type 2 diabetes accounts for more than 90 percent of the diabetes cases diagnosed in the United States, according to the FDA.

Lilly shares fell 66 cents, or 1.1 percent, to $60.40 in afternoon trading Friday. Its shares have risen almost 13 percent over the past year.

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