Sanofi gets FDA approval for type-2 diabetes treatment Adlyxin
pharmafile | July 28, 2016 | News story | Research and Development, Sales and Marketing | FDA, Lixisenatide, Lyxumia, Sanofi, adlyxin, approval, diabetes, type 2, type-2, zealand
Sanofi has announced that the US Food and Drug Administration (FDA) has approved Adlyxin (lixisenatide), which is a once-daily mealtime GLP-1 receptor agonist injection. It is indicated as an adjunct to diet and exercise for the treatment of adults with tyoe-2 diabetes.
Already approved in most EU countries, Japan, Brazil and India, among others, Adylxin has been launched as Lyxumia in many regions. It was in-licensed by Sanofi from Denmark-based Zealand Pharma.
The FDA’s approval is based on results from GetGoal clinical program and the ELIXA trial, which helped to confirm cardiovascular safety, as requested by the FDA. The GetGoal program features 13 clinical trials involving more than 5,000 adults. Each trial met the primary efficacy endpoint of blood glucose levels, or HbA1c, reduction.
Peter Guenter, executive VP of global diabetes and cardiovascular business unit at Sanofi, says: “Thje approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose targets. We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”
The approval has triggered a milestone payment of $5 million to Zealand. The company are eligible to receive remaining milestone payments of up to $135 million as well as royalties on global sales.
CEO Britt Meelby Jensen, comments: “Today is an important day for Zealand. With the FDA approval of Adlyxin we have successfully passed the final regulatory milestone for the first Zealand invented product to become available for diabetes patients in the significant US market. We look forward to Sanofi’s launch of Adlyxin, while awaiting the FDA’s regulatory decision on iGlarLixi, the single product combination of Adlyxin and Lantus, expected in August 2016.”
Sean Murray
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
