FDA Actions
October 1, 2014
The FDA has approved a once-weekly injectable GLP-1-receptor agonist for the treatment of type 2 diabetes. Dulaglutide is an ultra long-acting agent that can be used as monotherapy or in combination with other antidiabetic drugs including metformin, sulfonylureas, thiazolidinediones, or insulin. Approval was based on six clinical trials in more than 3300 patients with type 2 diabetes in which the drug improved blood sugar control and lowered HbA1c levels. As with other GLP-1 agonists, dulaglutide has been linked to thyroid C-cell tumors in rodents. Dulaglutide is marketed by Eli Lilly and Company as Trulicity.
An FDA panel has recommended limiting indications for use of testosterone supplements to specific medical conditions that impair testicular function. The Bone, Reproductive and Urologic Drugs Advisory Committee to the FDA voted overwhelmingly to limit use of the increasingly popular prescription testosterone products, recommending against use for age-related low testosterone levels. The panel also recommended research to study the cardiovascular risks of prescription testosterone products. If approved by the FDA later this year, the new rule would limit marketing and promotion of prescription testosterone products for otherwise healthy men with “low T,” a multibillion dollar market. Last year, 2.3 million men were prescribed testosterone with the majority being younger than the age of 65. The new rule may change the way health plans cover prescription testosterone as well. The FDA generally approves the recommendations of their advisory committees.
The FDA has revised the safety label for the smoking cessation drug varenicline (Chantix) after new studies indicate that it may not carry the risk of suicidality and other psychiatric disorders as previously thought. A meta-analysis of more than 1900 patients in five randomized trials found no increase in suicidality compared to placebo. Another large meta-analysis found no increase in mood disorders, including anxiety or depression. There has also been no evidence of increased neuropsychiatric hospitalizations. The FDA placed a black box warning on varenicline more than 5 years ago when initial data suggested an increase in neuropsychiatric problems with the drug. Pfizer, the drug’s manufacturer, is petitioning the FDA to remove the black box warning altogether, although the agency has not ruled on this yet.
The FDA has approved naloxegol for the treatment of opioid-induced constipation in adults. The drug is a peripherally acting opioid receptor antagonist that is available as a once-daily oral tablet. Safety and efficacy were established in two trials of 1352 participants with opioid-induced constipation in which 41-44% of patients experienced some relief compared to 29% improvement with placebo. Naloxegol is marketed by AstraZeneca as Movantik.
The FDA has approved a new combination of two older drugs — naltrexone and bupropion as a fixed-dose, extended-release formulation for the treatment of obesity in addition to a reduced-calorie diet and physical activity. It is approved for those with a body mass index (BMI) ≥ 30 kg/m2 with no risk factors or a BMI ≥ 27 kg/m2 associated with hypertension, type 2 diabetes, or dyslipidemia. The approval was based on several clinical trials of about 4500 obese and overweight patients in which the drug was associated with a weight loss of 4.1% over 1 year compared to placebo. Because the combination includes bupropion, there is a boxed warning regarding suicidal thoughts and behaviors associated with antidepressants. It should be avoided in patients with uncontrolled blood pressure and eating disorders. Naltrexone is an opioid antagonist, so the combination should be avoided in those taking opioids. Bupropion/naltrexone is marketed by Takeda Pharmaceuticals as Contrave. Contrave is the third drug approved for this indication after phentermine/topiramate (Qsymia) and lorcaserin (Belviq). Both drugs were approved in 2012 but have seen scant use in the United States.
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