The U.S. Food and Drug Administration (FDA) issued a warning on its website on Friday, May 15th regarding a popular oral type II diabetes class of medications known as SGLT2 inhibitors. The FDA warned that the increasingly popular class of drugs, which help blood sugar to be secreted in urine, has led to ketoacidosis, a condition in which the body produces a high level of blood acids known as ketones. The warning spells bad news for drug-makers AstraZeneca, Johnson & Johnson and Eli Lilly, and well as researcher, Boehringer Ingleheim. Each of these drug makers has a popular SGLT2 inhibitor on the market: AstraZenica’s Farxiga, Johnson and Johnson’s Invokana, and Lilly and Boehringer’s Jardiance. The FDA also issued a warning for popular combination drugs that include SGLT2 inhibitors: Johnson’s Invokamet, Astra’s Xigduo XR, and Lilly and Boehringer’s, Glyxambi.
The warning could cause the popularity of these drugs to wane, as they have been in high demand for their ability to help control weight and blood-pressure as well as manage blood-sugar. The FDA noted 20 adverse-event cases from March, 2013 through June 2014 involving ketoacidosis or ketosis that required emergency-room visits or hospitalization. They also said that additional adverse-event reports have occurred since that time-frame as well. The warning could also increase the demand for SGLT2 Inhibitors’ main rival, another oral diabetes medication class known as DPP4 inhibitors. This class includes Merck’s Januvia, the drug-maker’s biggest seller at $6 billion per year. This is welcome news for Merck and other DPP4 inhibitor makers, as research has recently cleared the drug class of heart safety accusations, which has dampened recent sales.
Reuters – Bill Berkrot