Drug For Rare And Fatal Disease Approved By FDA, But Given Black Box Warning
The warning is the strongest label the FDA can put on a prescription drug. In other news, the agency is banning the use of seven types of synthetic food additives.
Stat:
FDA Approves Akcea's Rare Disease Drug With A Black Box Warning
Akcea Therapeutics finally earned a U.S. drug approval. The Food and Drug Administration announced Friday it had approved the company’s drug, inotersen (Tegsedi), which aims to treat a rare and fatal condition known as hATTR. It’s a major win for Akcea, after the FDA declined to approve another of the company’s drugs, Waylivra, based on the same technology. But Tegsedi was approved with a black box warning — the strongest type the FDA can put on a prescription drug. (Sheridan, 10/5)
NPR:
FDA Bans Use Of 7 Synthetic Food Additives After Environmental Groups Sue
Ever heard of these food additives? Synthetically-derived benzophenone, ethyl acrylate, methyl eugenol, myrcene, pulegone, or pyridine? These compounds can help mimic natural flavors and are used to infuse foods with mint, cinnamon and other flavors. You've likely never seen them on food labels because food manufacturers are permitted to label them simply as "artificial flavors." (Aubrey, 10/6)
