An advisory committee for the European drug authority is recommending the approval of empagliflozin, a new type 2 diabetes drug made by Boehringer Ingelheim and Eli Lilly and Company.
Empagliflozin is in a new class of diabetes drugs known as sodium glucose co-transporter 2, or SGLT-2, inhibitors. It works by targeting glucose directly and works independently of B-cell function and insulin resistance. The drug produces increased urinary glucose excretion, with a consequent lowering of plasma, glucose levels, and weight loss. If approved, the empagliflozin would be marketed under the name Jardiance.
Earlier this month, the U.S. Food and Drug Administration (FDA) rejected empagliflozin saying Boehringer Ingelheim must first fix deficiencies at one of its manufacturing plants. Canagliflozin was the first SGLT-2 inhibitor to be approved in the United States. Dapagliflozin was rejected by the FDA but is approved in Europe.
Empagliflozin received a positive nod from the Committee for Medicinal Products for Human Use (CHMP), which advises the European Medicines Agency (EMA) on drugs and medical devices. The EMA is not required to follow the recommendations of its advisory panels, however it usually does. The EMA is expected to make a final decision on empagliflozin within two months.
In order to win approval from drug regulators, pharmaceuticals must demonstrate safety and efficacy. Diabetes treatment side effects are a primary concern. Clinical trials showed that a high frequency of patients treated with empagliflozin developed genital infections. Often, serious side effects are not fully known until years later.
For example, in 2011, studies showed the type 2 diabetes drug Actos increased the risk of bladder cancer. More recent studies have linked the diabetes drugs Januvia and Byetta with acute pancreatitis and pancreatic cancer.