FDA Reviews Breakthrough Drugs

In early June, the food and Drug Administration got the thumbs-up from expert panels on some potentially game-changing new drugs. The FDA doesn’t have to follow the panels’ advice (though it often does). Here’s what you need to know about the drugs that may be coming soon to a pharmacy near you.

‘Female viagra’ Is sexism to blame for the fact that men have several drugs to treat low libido and women have none? That’s the question raised by a campaign to get Sprout Pharmaceuticals’ women’s-libido drug, flibanserin, approved. The agency denied Sprout’s two previous attempts, citing concerns that the drug’s benefits did not outweigh potential side effects of nausea, drowsiness and low blood pressure. Now its panel recommends that it get the green light, but some experts say the drug is less about medicine than marketing. Desire can wane with age in men and women and for many reasons, but with male sexual-dysfunction drugs netting $4 billion a year globally, drugmakers likely see another lucrative market in the flagging libidos of women.

Cholesterol fighters As effective as the best-selling statins are at lowering cholesterol levels, it’s possible that going even lower could make a bigger dent in heart-disease rates. That’s in part why an FDA committee recommended approval of new drugs that drop cholesterol levels by up to 65%. But long-term data on whether the drugs can reduce heart attacks, strokes and other events–as well as deaths–isn’t available yet. So the panel advised that the new drugs, which are injected every few weeks, first be used in hard-to-treat cases.

–ALICE PARK