On Thursday, a new drug being developed by Johnson & Johnson was given backing by an advisory panel that voted 10 to 5 in favor of recommending the drug to the U.S. Food and Drug Administration.
If approved, the drug would be the first of a new type of medication in the United States that treats diabetes. Nevertheless, a number of the panel members raised concerns over the drug’s potential risks when used in patients suffering from impaired kidneys. They also were concerned with the cardiovascular risks the medication might have.
The drug is called canagliflozin and is one of a new type of drug that reduces the blood sugar level by causing the body’s sugar to be excreted in the urine. Existing treatments work by affecting insulin’s use or supply in the body.
Clinical trials performed by J&J of more than 10,000 participants around the world showed the new drug helped to improve blood sugar levels and led to some weight loss and a reduction in participants’ blood pressure. Adult patients with type 2 diabetes take the medication once every day. Medical experts predict that more than 26 million people in the United States suffer from type 2 diabetes.
Even some of the members of the advisory panel who voted for the drug’s approval voiced their concerns over side effects and urged the drug’s developer, Johnson & Johnson to follow closely the patients who were taking part in current long term safety studies. Some doctors have expressed worry about the drug being given to patients who suffer from moderate kidney disease.
Doctors also expressed their concern about a higher risk of suffering a stroke and a slight increase in heart attack risks.