A new compound named Albiglutide (Eperzan), was recently approved by The German Institute for Quality and Efficiency in Health Care (IQWiG) as a treatment for type 2 diabetes patients that have been unresponsive to diet and measures to achieve glycemic control.
The IQWiG based their endorsement of the drug on findings of Albiglutide’s superior therapeutic effect when combined with metformin. This, compared to the usual treatment of metformin combined with sulfonylurea, causes fewer hypoglycemic events, thus producing a minor additional benefit. Albiglutide alone has been also approved for patients that are unable to tolerate metformin.
Furthermore, it has been allowed in combination with other drugs whose function is to decrease the levels of glucose in the blood, such as insulin. This combination showed minor effects for those patients that are unable to control glycemic levels with insulin, diet and exercise alone. Albiglutide comes in the form of a single use pen that is injected under the skin once every week.
In terms of sub indications, The Federal Joint Committee (G-BA) raised four questions on A) albiglutide as monotherapy versus a sulfonylurea; B) as an add-on with another blood-glucose lowering drug also in comparison with metformin and sulfonylurea; C) in combination with at least two other blood-glucose lowering drugs in comparison with metformin and human insulin, D) and in combination with insulin also in comparison with metformin plus human insulin.
From these four questions, the drug company showed no data to address questions A, B and C. Therefore, conclusions cannot be drawn regarding the beneficial effects of the drug versus comparative therapies.
With regard to question B, the company presented data from one study, called HARMONY 3, where albiglutide in combination with metformin was studied in comparison to metformin with sulfonylurea glimepiride. Results presented revealed no significant differences between the two combinations in crucial clinical endpoints such as morbidity, symptoms and late complications. However, HARMONY 3 was not meant to assess these specific endpoints. In the company’s report, the IQWiG experts also mentioned that HARMONY 3 did not reveal differences in important clinical endpoints such as severe hypoglycemia, serious side effects and discontinuations due to adverse effects. From these outcomes, conclusions cannot be drawn on the beneficial effects of added albiglutide.
According to the results reported on the effects of albiglutide, the drug was found to be associated with fewer symptomatic hypoglycaemic events when compared to the other arm of the study involving glimepiride. This beneficial effect was found in the beginning of the study. “However, a fixed initial dose of 2 mg of glimepiride was envisaged in the study, and an increase to 4 mg for the next step, whereas the approval also allows a starting dose of 1 mg and 1 mg steps for individual dose adjustment in the course of the treatment,” according to a recent press release.
In this regard, the reported effects of the drug in HARMONY 3 are unclear, and albiglutide’s provision of clinical benefit is merely a suggestion. Although minor, there is a positive effect achieved from administering albiglutide in combination with metformin in symptomatic hypoglycaemia versus the appropriate comparator therapy.