Pharmacotherapy Updates and Recent FDA Action

In the second part of the “Late-Breaking Clinical Trials & FDA Update…” presentation, a panel of presenters provided a roundup of recently approve drugs and impending FDA action.

In the topic of acute coronary syndrome (ACS), Christopher Cannon, MD, highlighted the recent approval of dabigatran, an anticoagulant. The approval is important because there hasn’t been a new drug approved of this kind in 50 years, he said. The drug will be used in prevention of strokes and hemorrhage for artrial fibrillation patients. “This is a total game changer,” he said. It also does not requiring monitoring.

Cannon also highlighted two anti-platelet drugs. Clopidogrel (plavix), which is in the class thienopyridine (anti-platelet) is indicated for acute coronary syndrome and used in percutaneous coronary intervention (PCI). Recent FDA action required the drug to have a new black box warning indicating it has reduced effectiveness in patients who are poor metabolizers. The last anti-platelet highlighted was Ticagrelor (proposed as Brilinta) this drug is in the class — CPTP and is also indicated for ACS and PCI.

Robert Eckel, MD, highlighted pharmacotherapies for Obesity. He mentioned the recent FDA action of pulling Sibutramine (meridia) from the market, which leaves orlistat.

An FDA advisory committee meeting is scheduled for Dec. 7 to discuss Contrave, which is a combination of maltrexone and bupropion. Contrave is supposed to initiate weight loss by reducing appetite and increasing metabolism and address the reward system in the brain that causes food cravings.

While the FDA committee recently voted against approving Lorcaserin (APD-356) in September, a final decision will be made Oct. 28. The experimental drug has serotonergic properties and acts as an anorectic.

Keith Ferdinand, MD, discussed hypertension pharmacotherapy developments. Newly approved drugs are the generic Losartan Potassium and Hydrochlorothiazide; and the combination Tribenzor and Tekamlo.

Jay Skyler, MD, highlighted the recent issues with Rosiglitazine (Avandia), a class TZD drug. In July, an FDA panel had a mix vote on whether to keep it on the market, but on Sept. 23 the FDA decided to the drug may remain as a treatment, though it can only be used on new patients whose blood sugar cannot be controlled with pioglitazone.