FDA Panels Recommend Approval of New Drugs for Weight Loss, HIV Prevention

FDA advisory panels recommended approving a new weight loss drug and the first drug for HIV prevention, the Associated Press reported Thursday.

The anti-obesity drug lorcaserin did not receive approval in 2010, when the agency cited an increased risk for tumors in animal studies. The manufacturer has since provided data showing only a "negligible" risk. But the drug may pose increased risks for hypertension in patients with diabetes, as well as for valvular heart disease.

A separate advisory group recommended approval of the first drug to prevent HIV infection, also known as pre-exposure prophylaxis (PrEP). Truvada, a combination of tenofovir plus emtricitabine (TDF/FTC), is already approved to treat HIV infection.

In his blog HIV and ID Observations, Dr. Paul Sax writes, "the use of TDF/FTC for PrEP has been quite limited, for a whole lot of reasons — including ... [its] cost, and concerns about long-term toxicity."

The FDA is expected to make final decisions on both drugs in June.