The Food and Drug Administration on Friday approved the first of a new class of medicines to treat diabetes.
The drug, Invokana, will be sold by Johnson & Johnson and treats patients with type 2 diabetes in a new way, by causing blood sugar to be excreted in the urine. Many existing drugs work by affecting the supply or use of insulin.
"We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," Mary Parks, who oversees drugs for metabolic diseases at the FDA, said in a statement issued by the agency.
Invokana will be taken once a day. Clinical trials of more than 10,000 patients showed that it improved patients' blood-sugar levels and also led to weight loss and reductions in blood pressure.
But the drug, whose generic name is canagliflozin, also has potentially serious side effects. The clinical trials revealed some signs of elevated stroke risk and a small increase in patients experiencing heart attacks within the first 30 days of taking the medicine. The drug also was shown to raise LDL, or "bad" cholesterol levels, although it also raised the level of HDL, or "good" cholesterol.
The FDA is requiring Johnson & Johnson to conduct five post-marketing studies, including a clinical trial to more definitively determine if the drug increases the risk of heart attacks and strokes. Another of the studies will involve monitoring for other side effects such as cancers, pancreatitis and liver problems.
In January, members of an FDA advisory panel called on Johnson & Johnson to closely monitor patients who are enrolled in long-term safety studies. Some of the members, who voted 10-5 in favor of Invokana's approval, said they did not think the drug should be prescribed to people with moderate kidney disease.
The drug was not as effective in patients with moderate kidney disease, and they were at a higher risk for the negative side effects, compared to people with normal kidney function. Invokana is not recommended for patients with severe kidney disease.
An estimated 26 million Americans have type 2 diabetes, and many of the medications on the market come with side effects like weight gain and hypoglycemia, or a dangerous drop in blood sugar. Patients taking Invokana experienced fewer episodes of hypoglycemia than those taking another diabetes drug, glimepiride, or Amaryl, but a similar number as patients taking the drug sitagliptin, or Januvia.
Last year, the Food and Drug Administration rejected a similar drug, dapagliflozin from Bristol-Myers Squibb and AstraZeneca, because of safety concerns, including a possible increased risk of breast and bladder cancers. But it was approved in Europe in November under the name Forxiga.
Johnson & Johnson is also seeking approval in Europe for Invokana.
Wall Street analysts have predicted that Invokana could be a good seller for Johnson & Johnson. Lawrence Biegelsen, of Wells Fargo, has estimated that the drug could bring in $111 million this year, with sales increasing to $667 million by 2016. Johnson and Johnson said the wholesale price would be $8.77 per tablet, in line with some other diabetes drugs.