Lilly Gets CRL For Jardiance In Type I Diabetes Indication
Zacks Investment Research | Mar 22, 2020 09:29PM ET
Eli Lilly & Company (NYSE:LLY) 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 (CSE:NOVOb) A/S (NYSE:NVO) , Johnson & Johnson (NYSE:JNJ) and Merck (NYSE:MRK) among others.
Year to date, Lilly’s shares have declined 6.8% compared with the developing treatment for the coronavirus pandemic ,which has infected more than 300,000 people worldwide and taken14,000-plus lives.
Eli Lilly and Company Price
Original post
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.