Monday, Scynexis said in a filing (PDF) that a recent review of the drug's manufacturing process by GSK has triggered a recall of the product and a pause of all clinical trials testing the medicine.As part of GSK's review, Scynexis learned of potential cross-contamination risks during the manufacturing process of ibrexafungerp, which is marketed as Brexafemme.The company is not aware that any of its medicine has been contaminated. Scynexis said it has not received adverse event reports tied to contamination.
Following a recent review by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance, SCYNEXIS became aware that a non-antibacterial beta-lactam drug substance is manufactured using equipment common to the manufacturing process for ibrexafungerp.
Current FDA guidance recommends segregating the manufacture of beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people. In the absence of the recommended segregation, there is a risk of cross contamination.
It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound and SCYNEXIS has not received reports of adverse events established to be due to the possible beta-lactam cross contamination. Nonetheless, in light of this risk and out of an abundance of caution (and aligned with GSK’s recommendation), SCYNEXIS is recalling BREXAFEMME® (ibrexafungerp tablets) from the market and placing a temporary hold on clinical studies of ibrexafungerp, including the Phase 3 MARIO study, until a mitigation strategy and a resupply plan are determined.
I genuinely do not understand how someone screwed this one up, but I am going to guess that some QA folks and some manufacturing folks had a very, very bad day. Good luck to the drug substance manufacturer; that's gonna leave a mark.