May 30, 2013 | By Márcio Barra
NICE, the UK price regulatory agency, gave yesterday their final positive evaluation for Bristol-Myers Squibb and Astrazeneca’s new diabetes drug Forxiga (dapagliflozin), a new, first in class treatment for type II diabetes, allowing it’s commercialization in the UK.
The drug was first approved by the European Medicines Agency (EMA) back in November 2012, but NICE requested more information from the manufacturers, and asked its Decision Support Unit to conduct an in-depth review of the economic analysis provided by the manufacturer, alongside an exploratory analysis of the drug in dual therapy and as an add-on to Insulin. The drug wasn’t approved in the USA due to cardiovascular concerns expressed by the FDA.
NICE’s approval and draft guidance recommend Forxiga as a dual-therapy drug for patients with type II diabetes, either in combination with metformin, or with insulin. It’s not recommended as part of a triple-drug regimen (Forxiga + Metformin + Insulin). The approval also recommends the use of Forxiga alongside Metformin when a sulphonylurea can’t be used. Moreover, combining Forxiga with metformin may be preferable to a thiazolidinedione if further weigh gain is a concern.
Forxiga is a drug with a novel first-in-class mode of action. It works by inhibiting the subtype 2 of the sodium-glucose transport proteins, responsible for 90% of glucose reabsorption in the kidney, effectively pushing blood glucose out of the body through the kidneys.
Final guidance from NICE is expected in June.