Following in EU regulators' footsteps, the U.K. has reportedly launched a probe into potential suicide risks for popular diabetes and weight-loss drugs.
Sanofi Aventis Adlyxin (Lixisenatide) Receives Approval in the U.S.
Sanofi Soliqua Insulin Glargine:Lixisenatide Receives Approval in the U.S.
READING, ENGLAND – 16 April 2020 – Sanofi has today announced that the Scottish Medicines Consortium (SMC) has recommended Suliqua™ for restricted use in combination with metformin for the treatment of adults with type 2 diabetes in Scotland.1 It can be used to improve glycaemic control when this has not been provided by metformin alone, or metformin combined with another oral glucose-lowering medicinal product or with basal insulin.1 The SMC has restricted the use of Suliqua to use in patients who are uncontrolled on basal insulin (glycosylated haemoglobin [HbA1c] > 7.5% [59mmol/mol]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin analogues. The combination improved glycaemic control compared with insulin glargine alone in adults with inadequately controlled type 2 diabetes mellitus.1 By year five of Suliqua being in Scotland, it is estimated that 4,485 people living with type 2 diabetes could be eligible for this treatment.1
Diabetes hits patients of all ages, ethnicities, weights, heights, occupations and personalities. Why wouldn't diabetes treatment take on as many different forms? That's the question Sanofi asks in a new awareness campaign. The “Diabetes Your Type” effort looks to move the needle on how and why individualized care is important for people with diabetes—and also to highlight Sanofi’s work on several fronts to personalize treatment.
The US Food and Drug Administration (FDA) has approved the expanded use of Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin or lixisenatide, Soliqua 100/33 can now also be prescribed for patients uncontrolled on oral antidiabetic medicines.
Sanofi-Aventis’s Suliqua Insulin Glargine(Lixisenatide) Receives Approval In Europe
The antibiotic, eravacycline, is being studied in a pivotal 450-patient Phase III trial for intra-abdominal infections. Tetraphase expects to have the data in the fourth quarter after which it will apply for U.S. approval that could come in 2018.
The therapy is a fixed-ratio combination of insulin glargine, a basal insulin analogue, and lixisenatide, a glucagon-like peptide 1 (GLP-1) receptor agonist. Insulin glargine binds specifically to the human insulin receptor while lixisenatide acts via enhancing glucose-dependent insulin secretion and reducing glucagon release.
Zealand Pharma (Zealand) today announced a USD 10 million milestone payment following Sanofi's announcement of European Commission (EC) marketing authorization in Europe for Suliqua(TM), the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. Suliqua(TM) is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.