FDA Actions
Despite the favorable news for empagliflozin, the news for another SGLT2 inhibitor is not so good. The FDA has strengthened the warning regarding bone loss and fracture risk associated with the diabetes drug canagliflozin (Invokana). The FDA warning notes that fractures can occur as early as 12 weeks after starting canagliflozin. The drug has also been linked to decreases in bone mineral density at the hip and lower spine. The FDA is evaluating whether other SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), have similar effects on bone (www.fda.gov/Safety/Medwatch).
The FDA has approved cariprazine to treat schizophrenia and bipolar disorder in adults. The drug is a partial agonist of D2 and D3 dopamine and 5-HT1A serotonin receptors. It is taken orally once a day at a recommended dosage of 3-6 mg for bipolar manic or mixed episodes and 1.5-6 mg for schizophrenia. Efficacy in treating schizophrenia was demonstrated in three studies of more than 1700 patients in which the drug showed superiority to placebo. Efficacy in treating bipolar disorder was shown in three trials of more than 1000 subjects in which the drug was shown to reduce the symptoms of bipolar disorder in each trial. Cariprazine, similar to all FDA-approved drugs for schizophrenia and bipolar disorder, carries a boxed warning regarding higher risk of death in patients with dementia-related psychosis. Most common side effects are extrapyramidal symptoms, including tremor, slurred speech, involuntary muscle movements, akathisia, and gastrointestinal symptoms. Cariprazine is manufactured by Forest Laboratories and distributed by Actavis Pharma as Vraylar.
The FDA has approved insulin degludec, a new long-acting insulin analog, as a standalone product and in combination with insulin aspart (70/30). Insulin degludec has a duration of action of up to 40 hours, the longest of any insulin analog, allowing its use as once-daily basal insulin. The efficacy and safety of insulin degludec in combination with mealtime insulin in type 1 diabetics was evaluated in two 26-week and one 52-week active-controlled clinical trials of more than 1100 patients. Safety and efficacy in type 2 diabetics was shown in six studies of more than 2700 patients who were also on oral medications or mealtime insulin. The 70/30 combination was evaluated in a study of 362 type 1 diabetics also taking mealtime insulin, and 998 type 2 diabetics in whom the combination was given once or twice a day. In all studies, A1c reductions were in line with reductions achieved with other previously approved long-acting insulins.
FDA strengthens warning about canagliflozin, approves cariprazine to treat schizophrenia and bipolar disorder, and green lights insulin degludec, a new long-acting insulin analog.
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