FDA approves Synjardy XR tablets for adults with type 2 diabetes
New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise.
FDA has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. When used along with diet and exercise, Synjardy XR is indicated to improve blood sugar in adults with type 2 diabetes when both empagliflozin and metformin can be taken. It is marketed by Boehringer Ingelheim and Eli Lilly.
Synjardy XR is a combination of empagliflozin and metformin — two medicines with complementary mechanisms of action — to help improve blood glucose in adults with type 2 diabetes. Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Synjardy XR is the fourth FDA-approved treatment that contains empagliflozin. Metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.
"Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage their condition," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "With Synjardy XR, the eighth FDA-approved treatment to emerge from our partnership with Lilly, adults with type 2 diabetes now have another convenient daily option to help them reach their glycemic goals, whether they are already being treated or are just at the beginning of their treatment."
The FDA approval of Synjardy XR is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes. Synjardy XR is not for the treatment of type 1 diabetes or diabetic ketoacidosis.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance