FDA Actions
June 1, 2014
The FDA has approved vorapaxar, a first in class oral antiplatelet agent to reduce the risk for myocardial infarction (MI), stroke, cardiovascular death, and revasculariztion in patients with a history of MI or peripheral artery disease. The drug is a protease-activated receptor-1 antagonist that prevents platelet aggregation. Vorapaxar increases the risk of bleeding and is contraindicated in patients who have had a stroke, transient ischemic attack, or intracranial bleeding. The drug was approved on the basis of one study that showed that it resulted in a 1.6% lower absolute risk of MI, stroke, or cardiovascular death over 3 years (9.5% vs 7.9%) but with a higher risk of bleeding. Vorapaxar is made by Merck and will be marketed as Zontivity.
The FDA is planning on investigating generic versions of extended-release metoprolol (Toprol XL). The investigation is the result of nearly 3500 adverse incident reports in the last 6 years, including lack of effectiveness and troublesome side effects. The FDA will assess whether generics are chemically the same as the branded product. There are also questions about the efforts to copy the delayed-release capsule of the original. The generics in question are manufactured in India and the United States.
The FDA has approved omega-3-carboxylic acids as an adjunct to diet to treat severe hypertriglyceridemia (levels ≥ 500 mg/dL). The product is the first omega-3 in free fatty acid form that allows dosing to be as few as two capsules once a day. This product joins two other prescription omega-3 supplements on the market for the same indication. The new omega-3 product is manufactured by AstraZeneca and marketed as Epanova.
The FDA has completed a safety evaluation of dabigatran (Pradaxa) in 134,000 Medicare patients, comparing the drug to warfarin in patients being treated for stroke prevention with atrial fibrillation. The study looked at the risk of ischemic or embolic stroke, brain hemorrhage, major gastrointestinal (GI) bleeding, MI, and death in patients ≥ 65 years of age. Compared to warfarin, dabigatran was associated with a 20% lower risk of embolic stroke, 66% lower risk of brain hemorrhage, and 14% lower death rate, although there was a 28% higher risk of GI bleeding. The MI risk was similar. These findings are similar to those of clinical trials that led to the drug’s approval (RE-LY). As a result, the FDA considers dabigatran to have a favorable benefit-to-risk profile and is not recommending any labeling changes.
The FDA is requiring labeling changes for eszopiclone (Lunesta) that would lower the starting dose from 2 mg to 1 mg at bedtime for both men and women. Data show that the higher initial dose may result in blood levels the next morning that are high enough to impair activities that require alertness, including driving. The 1 mg dose can be increased to 2 mg or even 3 mg if needed. The change is partially the result of a study of 91 healthy younger adults which showed that compared to placebo, eszopiclone 3 mg was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug, and the effects can last as long as 11 hours. The patients were generally unaware they were impaired. This is the second “z-drug” dose reduction — last year the FDA recommended a similar dose reduction for zolpidem (Ambien, Ambien CR).
The FDA has approved a new GLP-1 agonist for the treatment of adults with type 2 diabetes. Albiglutide is approved for monotherapy or in combination with existing treatment options, including metformin, glimepiride, pioglitazone, or insulin. The drug’s approval was based on eight clinical trials of more than 2000 patients with type 2 diabetes that showed a modest improvement in HbA1c levels. The drug comes with a boxed warning regarding thyroid tumors. Albiglutide is marketed by GlaxoSmithKline as Tanzeum.
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