AstraZeneca's Farxiga Gets CRL From FDA For Type I Diabetes
Zacks Investment Research | Jul 15, 2019 05:43AM ET
AstraZeneca (NYSE:AZN) announced that the FDA has issued a complete response letter (“CRL”) to its supplemental new drug application (sNDA) for SGLT2 inhibitor, Farxiga (dapagliflozin). The sNDA sought approval for label expansion of Farxiga as an adjunct treatment to insulin to improve glycemic control in type I diabetes patients in whom insulin has inadequate response.
The details of the CRL have not been announced. The company will meet with the FDA to discuss the CRL and seek the path forward for the sNDA. The sNDA was filed based on data from the phase III DEPICT study. Data from the study showed that both the 5mg and 10mg doses of Forxiga led to significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 weeks.
In March, Forxiga was approved for a similar indication in Europe and Japan. Farxiga/Forxiga is already approved as both monotherapy and combination therapy to improve glycemic control, with additional benefits of weight loss and blood pressure reduction as an adjunct to diet and exercise in adults with type-II diabetes.
Please note that, in March, the FDA also issued a CRL to Lexicon Pharmaceuticals, Inc.’s (NASDAQ:LXRX) new drug application seeking approval for Zynquista, a dual SGLT1 and SGLT2 inhibitor, in combination with insulin as a treatment for type I diabetes. The details of the CRL were not available. Lexicon is developing the candidate in collaboration with Sanofi (NASDAQ:SNY) .
It may seem that SGLT inhibitors have adequate response in type II diabetes patients. However, these face some hurdles in type I diabetes patients. It has been observed that SGLT inhibitors carry the risk of diabetic ketoacidosis, a serious complication of diabetes. In both CRLs, the concerned companies are working with the FDA to sort out any issues. There is no approved SGLT inhibitor for type I diabetes in the United States.
AstraZeneca’s stock has increased 5.8% this year so far, outperforming the industry ’s decrease of 1.6%.
Farxiga/Forxiga, a key driver of AstraZeneca’s top line, recorded sales of almost $349 million in the first quarter of 2019, representing growth of 23%. Farxiga, one of the many successful new drugs in AstraZeneca’s portfolio, enjoys volume market share leadership globally.
Get The News You Want
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s (NYSE:JNJ) Invokana and Lilly’s Jardiance, Synjardy (a fixed dose combination of Jardiance and metformin) and Glyxambi (a fixed dose combination of Jardiance and Tradjenta).
Zacks Rank
AstraZeneca currently carries a Zacks Rank #4 (Sell).
You can see .
Wall Street’s Next Amazon (NASDAQ:AMZN)
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Zacks Investment Research
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.