FDA refuses to review Alkermes’ depression drug, demands additional clinical trials

The FDA has told Alkermes it needs to see data from “additional well-controlled clinical trials” before it will review a filing for approval of depression drug ALKS 5461. Alkermes plans to appeal the ruling, but at this stage it looks like the biotech’s attempt to get a mixed set of data past the FDA has failed.

• Source: fiercebiotech
• 702
• April 6, 2018