Lixisenatide Approved By the EU and Being Reviewed By the FDA

Lixisenatide Approved By the EU and Being Reviewed By the FDA

As a treatment for Type 2 diabetes lixisenatide is approved by the EU and currently under review as a New Drug Application {NDA} by the FDA. Sanofi is preparing to launch lixisenatide in the European Union as in the latter of first quarter 2013, with the proprietary name Lyxumia. What makes lixisenatide unique is not only the evidence of significant reductions in HbA1c in clinical trial patients, but also the exemplary safety and tolerability profile of this drug. In addition, lixisenatide has been evaluated in extensive global trials, including the GetGoal trial, which was comprised of 11 clinical trials involving more than 5,000 patients with Type 2 diabetes. The GetGoal Phase III program demonstrated that a once daily dose of lixisenatide significantly reduced glycated hemoglobin in patients with Type 2 diabetes while also reducing post-prandial glucose. Patients in this study also displayed a decrease in body weight, which was a beneficial effect of lixisenatide. In terms of tolerability, clinical trial patients presented with mild and transient adverse effects, such as mild nausea, vomiting, and diarrhea.

The total number of diabetes patients in the world is expected to grow to 425 million by the year 2030, making the need for novel, tolerable and effective medications urgent. Type 2 diabetes affects millions of Americans, and it is the most common form of diabetes worldwide. Many patients are currently at a high risk for Type 2 diabetes, and are unfortunately unaware of this impending disease. There are also certain groups of patients who are at a higher risk of Type 2 diabetes, including African Americans, Asians, Latinos, Native Americans, Pacific Islanders and Native Hawaiians. LGM Pharma offers API lixisenatide, CAS number 320367-13-3, for research and development purposes. Clients can be assured of quality products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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