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Lilly Gets CRL for Jardiance in Type I Diabetes Indication

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Eli Lilly & Company (LLY - Free Report) announced that the FDA issued a complete response letter (“CRL”) for its supplemental new drug application (sNDA) seeking label expansion of its SGLT-2 inhibitor, Jardiance (empagliflozin) 2.5 mg for type I diabetes. Please note that Jardiance is already marketed for treating type II diabetes.

The sNDA filed by Lilly and partner Boehringer Ingelheim sought approval for empagliflozin as an adjunct to insulin for treating type I diabetes patients, under a separate brand name. The FDA stated in its CRL that it was unable to approve empagliflozin’s sNDA in its current form.

Please note that the FDA’s Endocrinologic and Metabolic Drugs Advisory had voted against the label expansion in November last year, suggesting that the benefits of Jardiance 2.5 mg do not outweigh the risks to support approval for the indication.

The sNDA included data from two phase III studies under the EASE program. Data from the EASE studies have shown that empagliflozin 2.5 mg plus insulin led toa statistically significant reduction in A1C versus plus placebo. Meanwhile, empagliflozin treatment led to reduction in weight and decrease in systolic blood pressure, which were the secondary endpoints.

Jardiance is a key top-line driver for Lilly. Its sales surged 43% year over year to $944.2 million in 2019, driven by increased demand trends within the SGLT2 class of diabetes medicines in the United States and higher volume outside the United States.

However, we note that while the diabetes market holds immense commercial potential, it is pretty crowded with the presence of companies like Novo Nordisk A/S (NVO - Free Report) , Johnson & Johnson (JNJ - Free Report) and Merck (MRK - Free Report) among others.

Year to date, Lilly’s shares have declined 6.8% compared with the industry’s decrease of 20.9%.

In a separate press release, Lilly stated that it will provide drive-through testing for COVID-19 infection of health care workers in Indianapolis area. The company is also working with the Indiana State Department of Health for testing COVID-19 samples acquired at local hospitals.

Earlier this month, Lilly collaborated with AbCellera to co-develop antibody products for the treatment and prevention of COVID-19. Along with Lilly, several large pharma companies as well as smaller biotechs are engaged in developing treatment for the coronavirus pandemic,which has infected more than 300,000 people worldwide and taken14,000-plus lives.

Zacks Rank

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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