The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation (MA) for Novo Nordisk’s Ozempic (semaglutide) to treat type 2 diabetes mellitus in adults.
Ozempic is an analogue of human glucagon-like peptide-1 and was reviewed based on the results of eight Phase IIIa clinical trials in the SUSTAIN programme.
The drug is recommended to be taken once-weekly as a monotherapy in cases where metformin is not a sufficient treatment or is contraindicated. The drug should be administered in combination with other diabetes medicines.
As part of the approval, the firm is set to perform post-approval safety studies such as a long-term diabetic retinopathy outcome trial.
Similar to other long-acting GLP-1 products approved in the EU, Ozempic will be registered in the data collection for the registry of medullary thyroid carcinoma.
Novo Nordisk executive vice-president and chief science officer Mads Krogsgaard Thomsen said: “We are very excited about the positive opinion for Ozempic for treatment of people with type 2 diabetes in Europe, many of whom are still looking for new and more efficacious solutions to better manage their disease.
“We believe Ozempic, with its unique clinical profile, has the potential to set a new standard for treatment of type 2 diabetes.”
The firm anticipates that the final MA from the European Commission (EC) will be received in Q1, 2018.