First drug in new class approved

The FDA recently approved canaglifozin (Invokana) tablets to improve glycemic control in adults with type 2 diabetes, along with diet and exercise.

The drug is the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved. Safety and effectiveness were evaluated in nine clinical trials of over 10,000 patients, which showed improvements in hemoglobin A1c and fasting plasma glucose. The drug has been studied as a stand-alone therapy and in combination with metformin, sulfonylureas, pioglitazone and insulin. It should not be used in patients with type 1 diabetes, diabetic ketoacidosis, severe renal impairment or end-stage renal disease. The most common side effects were vulvovaginal candidiasis and urinary tract infection. Because the drug is associated with a diuretic effect, it can cause a reduction in intravascular volume leading to orthostatic or postural hypotension.

The FDA is requiring five postmarketing studies: 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; a bone safety study; and two pediatric studies.