I spoke to Zack at the FDA yesterday something he said to me alarmed me. The investigation of Omontys was still continuing however, he said explicitly they were investigating what was causing the anaphylactic shock. (as opposed to why people died of anaphylaxis) That would be a big shift of focus from administration and procedure (what I thought) to formulation.
If someone else wants to confirm this or just perhaps have a fresh pair of ears on the phone the number is One-Eight Eight EIght-INFO-FDA, and just follow the options.
Thanks for sharing this. If this is true ( I believe you), then this is a great news. Almost as close it can get to final public disclosure of O returning to market. As Maxdad said in his post below anaphylaxis is not a very difficult issue to encounter. Also this a specific condition found in specific individuals not a widespread issue. Had they been investigating on the safety/ efficacy of the drug itself, then it would have been a concern. To me it seems that the study would help to describe the exclusions on the label I.e persons with..... should not take this or should be given under a supervision of a specialist..
Once again this should be taken as a very positive news and also it corroborates with what Fresenius said in their Cc
Of course Takeda's investigation into O's high incidence of adverse patient reactions, including death, and its plan of correction to O is going to focus on all aspects of O, whether it be error in procedure and administration or, as you suggest, to O's inherent patient safety profile. The voluntary recall is a serious Class I recall which requires O to undertake corrections to make O safe. PEARL studies proved O was unsafe for the healthier CKD patients not on dialysis. The EMERALD studies "proved" O was safe for the "sicker" CKD patients on dialysis. AFFY called these ironic results "inexplicable". Now that actual patient usage of O by these sicker CKD patients on dialysis appears also to establish that O is unsafe for these patients, too, the EMERALD studies data is probably being questioned. Indeed, at the time Takeda withdrew O's EMA MAA, the CHMP issued a statement that Takeda's study results filed in support of O's MAA for CKD patients on dialysis could be "unreliable data". As another example, RW Baird analyst Christopher Raymond's research, made after O was recalled, concluded "[L]ooking at FDA’s adverse event database for Epogen, Omontys appears to confer a 100-fold higher incidence of hypersensitivity and an 8.5-fold higher incidence of drug-related death (and that’s new). This analysis isn’t perfect, but we think the magnitude is such that there’s a clear signal here.” The FDA was concerned about O's safety at the time it approved O which is why it imposed the REMS. It seems the FDA's REMS worked when disastrous O patient safety profile in actual usage became more in line with what the PEARL studies proved about O leading to O's "voluntary" recall.