Ozempic, a once-weekly injection of glucagon-like peptide-1 (GPL-1), was approved following information from research which revealed the drug improved HbA1c ranges and likewise permits weight reduction.
The Novo Nordisk drug will now grow to be accessible in the US in zero.5mg and 1.0mg doses, to be administered as soon as per week utilizing a devoted prefilled pen system.
Ozempic can be beneath assessment for approval by the European Medicines Agency following submission by Novo Nordisk in 2016.
The FDA’s choice was made following an advisory panel endorsement in October, the place scientific trials involving greater than eight,000 adults with type 2 diabetes have been reviewed.
In 5 SUSTAIN trials, Ozempic lowered HbA1c by 17 to 20 mmol/mol (1.5 to 1.eight%), and outperformed one other GLP-1 agonist, Bydureon (exenatide), in certainly one of the trials.
Ozempic was additionally related to weight lack of between four.5-6.4kg, and research have demonstrated Ozempic can cut back the threat of coronary heart illness.
Mads Krogsgaard Thomsen, govt vp and chief science officer at Novo Nordisk, mentioned: “We are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the US with type 2 diabetes in the beginning of 2018.”
Side results of the drug included gentle to reasonable nausea, vomiting and constipation, however these weakened over time.
Earlier this yr an oral model of semaglutide was proven to have related advantages to injectable semaglutide, however additional analysis must be performed earlier than that is despatched for approval.
Editor’s word: People with type 2 diabetes who’ve joined our Low Carb Program have come off medicine altogether by making life-style adjustments, similar to consuming a nutritious diet, and normalising their blood sugar ranges. The program may assist with weight reduction and enhancing general well being.