Back to top

Analyst Blog

Eli Lilly and Company (LLY - Analyst Report) and partner Boehringer Ingelheim suffered a regulatory setback with the U.S. Food and Drug Administration (FDA) issuing a Complete Response Letter (CRL) for their New Drug Application (NDA) for empagliflozin, investigational sodium glucose co-transporter-2 (SGLT2) inhibitor. Eli Lilly and Boehringer Ingelheim are looking to get the candidate approved for the treatment of type II diabetes.

The FDA mentioned in the CRL that the deficiencies observed previously at the Boehringer Ingelheim manufacturing facility, where empagliflozin will be produced, have to be resolved in order to gain approval for the candidate. Importantly, the agency did not ask the companies to conduct additional studies.

Eli Lilly and Boehringer Ingelheim said that they are working with the FDA to submit a response to the CRL and resolve the issues mentioned in it.

The delay in FDA’s decision on empagliflozin, while disappointing, is not really surprising as the Boehringer Ingelheim manufacturing facility had already received a warning letter from the FDA and chances remained that this would delay the approval of empagliflozin.

However, Eli Lilly needs to bring new products to market considering key products like Cymbalta and Zyprexa are facing stiff generic competition. A generic version of Evista will also be launched shortly. Meanwhile, SGLT2 inhibitors like Johnson & Johnson’s Invokana (JNJ - Analyst Report) and AstraZeneca’s (AZN - Analyst Report) Farxiga will get a head start in the type II diabetes market.

Eli Lilly carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma sector is Novo Nordisk (NVO - Analyst Report) with a Zacks Rank #2 (Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
CTPARTNERS… CTP 13.33 +3.49%
SAIA INC SAIA 45.65 +1.00%
VASCO DATA… VDSI 13.57 +0.67%
AMEDISYS IN… AMED 20.18 +0.10%
FIRSTSERVIC… FSRV 55.66 -0.13%