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.
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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.
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By GlobalData“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.
