First oral GLP-1 treatment for type 2 diabetes recommended by EMA

The European Medicines Agency’s human medicines committee has recommended the first oral glucagon-like peptide (GLP-1) receptor agonist treatment for adults with uncontrolled type 2 diabetes mellitus (T2DM).

At a meeting on 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for Rybelsus (semaglutide; Novo Nordisk) for the treatment of adults with insufficiently controlled T2DM, to improve glycaemic control as an adjunct to diet and exercise. 

GLP-1 receptor agonists are a class of non-insulin medicines for people with T2DM that work to reduce blood glucose by stimulating pancreatic secretion of insulin and lowering the secretion of glucagon when blood sugar is high.

As an oral medicine, Rybelsus could provide patients with another option to treat the disease, without the need for injections.

Vicky Ruszala, specialist diabetes pharmacist at North Bristol NHS Trust, described the recommendation as a “really positive step” but warned that the practicalities associated with making the medicine available to patients could restrict its overall use.

“[This medicine] has been long awaited,” she said. “Being oral, it overcomes major barriers [associated with injections], however, this is an oral protein and the research and development costs are likely to be huge.

“Until we know the cost [of the medicine to the NHS] we won’t know the impact,” she added, highlighting that if the final cost was high the National Institute for Health and Care Excellence may recommend subcutaneous over oral use.

Ruszala also said that compliance to the medicine, which needs to be taken at a set time before eating, may also be an issue.

“The clinical evidence is really good but the administration is complicated — whether it will be as efficacious in real life as it was in trials, I don’t know,” she said.

The safety and efficacy of Rybelsus was studied in eight clinical trials that included patients at various stages of the disease. In three of the studies, Rybelsus was compared to a placebo. In the development program, it was either used on its own, added to the standard treatment or compared to a GLP-1 injection treatment.

The CHMP’s opinion will now be sent to the European Commission for a decision on granting the marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place.