Pharmaceutical

European Union approves new combination treatment for type 2 diabetes

diabetes illus250x03 European Union approves new combination treatment for type 2 diabetes European Union drug regulators have approved a new combination pill to treat type 2 diabetes. Vokanamet combines the new diabetes drug Invokana with the standard treatment metformin. The new treatment is made by Johnson & Johnson and will be marketed in Europe by Janssen-Cliag International.

The active ingredient in Invokana is canagliflozin, which is in a class of diabetes medications known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs are designed to help reduce blood sugar levels by preventing the reabsorption of glucose from the kidneys back into the blood, and allows glucose to be excreted in the urine.

The U.S. Food and Drug Administration (FDA) approved Invokana in March 2013, and the European Union approved the drug in November 2013. However, the FDA’s approval of Invokana requires the drug maker to perform five postmarketing studies including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities and adverse pregnancy outcomes; and a bone safety study.

The most common side effects with Invonkana includes vaginal yeast infections and urinary tract infections, however researchers say SGLT2 inhibitors may be linked to more serious side effects.

Closer tracking of serious adverse events with type 2 diabetes is often required because some harmful effects with some drugs are not immediately clear. For example, long-term use of the type 2 diabetes drug Actos was linked to bladder cancer. The FDA is also currently investigating reports of acute pancreatitis and pancreatic cancer with the type 2 diabetes drugs Byetta and Januvia.

Source: PharmPro