FDA crack down on drugs whose clinical trials indicate potential for anaphylaxis bodes ill for O and AFFY
Merck annnounced today that the Food and Drug Administration rejected its anesthesia drug Bridion for the second time.
The first rejection was back in 2008 when Schering-Plough still owned the drug. The FDA went against a unanimous recommendation by its advisory committee and rebuffed the drug, requesting additional data on its potential effect on hypersensitivity.
Merck bought Schering-Plough in 2009, started marketing Bridion in more than 50 countries where it's approved for sale, and ran a study to help convince the FDA that the drug was safe.
Rather than providing its blessing, however, the FDA now has "concerns about operational aspects" of the clinical trial. It appears the agency is concerned about a specific clinical trial site that conducted the hypersensitivity study.
What can AFFY longs infer from this? From the lawsuit allegations: AFFY knew about serious allergic reactions from EMERALD studies, but hid the results. Moreover, O's FDA advisory panel questioned O's EMERALD safety studies reliability due to its open label nature and high rate of patient drop out and inconsistency with O's PEARL safety studies results. The EMA, at the time Takeda withdrew its O MAA, commented that the study results Takeda filed in support of O might not be reliable.
It may be impossible for Takeda under such circumstances to convince the FDA to allow O back to market "in the near future" as AFFY says it must in order to survive financially.