On February 23, peginesatide was recalled because of 5 deaths and many reactions. Since then Affymax shares havegone into free fall, nearly all or soon to be all Affymax employees will be laid off and the web is replete with lawyers eager to sue Affymax. Why an unimaginable disaster? The drug was approved by the FDA less than 1 year previously 2 New England Journal articles had just been published, and )rumor has it) Affymax was on the brink of signing up one of the LDOs. Yes, Feb 23 was the day the music died for peginesatide.
A recent article in the Wall Street Journal claims that the reactions started occurring soon after the drug was marketed and the company approached the FDA to insert a warning. My question: since the NEJM paper was published in January 2013, shouldn't the company have warned the nephrology community about these risks? (the FDA label for peginesatide is here)
An excerpt from the WSJ article:
In an interview shortly after the lots were recalled, Affymax's chief executive, John A. Orwin, said, "In the fall, we had seen a few cases that were more severe." At that time, the company contacted the FDA about adding a warning on the drug's packaging. The company said these reactions occurred in some patients within 30 minutes of the drug's infusion.
In that interview, Mr. Orwin said the company was studying whether a manufacturing flaw, or the drug itself, was responsible for the patients' reactions. Mr. Orwin didn't respond to several requests for comment and information in recent days. Takeda said it is working closely with the FDA.
The first adverse event report was received at the FDA Aug. 14. It said Omontys was suspected as having caused a 57-year-old woman to go into a life-threatening anaphylactic reaction.
Within days, other cases popped up across the country as the drug began being used more broadly at U.S. dialysis centers. A report to the FDA on Aug. 17 talked about a woman hospitalized for a "hypersensitivity reaction" who struggled to breathe. Another on Aug. 20 reported that a 61-year-old man had a life-threatening anaphylactic reaction.
By Oct. 31 of last year, Affymax proposed to the FDA that the drug's label include a warning related to serious allergic reactions, and such language was added to the label."
A recent article in the Wall Street Journal claims that the reactions started occurring soon after the drug was marketed and the company approached the FDA to insert a warning. My question: since the NEJM paper was published in January 2013, shouldn't the company have warned the nephrology community about these risks? (the FDA label for peginesatide is here)
An excerpt from the WSJ article:
In that interview, Mr. Orwin said the company was studying whether a manufacturing flaw, or the drug itself, was responsible for the patients' reactions. Mr. Orwin didn't respond to several requests for comment and information in recent days. Takeda said it is working closely with the FDA.
The first adverse event report was received at the FDA Aug. 14. It said Omontys was suspected as having caused a 57-year-old woman to go into a life-threatening anaphylactic reaction.
Within days, other cases popped up across the country as the drug began being used more broadly at U.S. dialysis centers. A report to the FDA on Aug. 17 talked about a woman hospitalized for a "hypersensitivity reaction" who struggled to breathe. Another on Aug. 20 reported that a 61-year-old man had a life-threatening anaphylactic reaction.
By Oct. 31 of last year, Affymax proposed to the FDA that the drug's label include a warning related to serious allergic reactions, and such language was added to the label."
