Life-threatening reactions to the anemia drug Omontys began appearing within months of when the treatment went on the market, according to a review of regulatory records.
Adverse-event reports to the Food and Drug Administration, obtained under the federal Freedom of Information Act, show for the first time how early the drug's worrisome reactions emerged. Omontys, from Affymax Inc. AFFY +10.89% and Takeda Pharmaceutical Co. 4502.TO -2.14% Ltd., was linked to allergic reactions and respiratory distress beginning in August 2012, shortly after it went on the U.S. market in late April.
The drug, which is used in kidney dialysis patients, is now in regulatory limbo. Last month, Affymax recalled all existing lots of the drug on account of the severe reactions and deaths—a move that sent its shares plummeting. But the FDA didn't officially pull the drug from the market.
The agency is now evaluating various factors to decide whether the drug can be sold in the future. Earlier this month, Affymax said it would cut its workforce by 75% and is considering selling itself.
A total of 98 "adverse events" tied to the drug were reported to the FDA by Feb. 22 of this year, the day before the recall. There were 12 deaths among the reports to the FDA, but the cause of death wasn't specified, and the patients getting dialysis and Omontys are by definition already very sick. Takeda said there were five deaths that the companies considered in deciding to recall Omontys lots on Feb. 23.
The events included anaphylaxis, an acute allergic reaction in which the airways constrict and patients struggle to breathe, blood pressure plummets and the heart may beat erratically and be unable to pump enough blood.
Affymax's chief medical officer, Anne-Marie Duliege, said the company has complied with all regulatory requirements and that it is working closely with the FDA. She declined further comment.
Omontys, generically called peginesatide, has been used in more than 25,000 patients and is generally more convenient than other anemia drugs in that it can be infused once monthly. Other drugs generally are given a dozen or more times a month.
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.
Fresenius Medical Care AG, FME.XE -0.45% which operates 1,800 dialysis facilities in the U.S., said it has used Omontys in over 18,000 patients.
It said that shortly after it expanded use of the drug in February, on Feb. 11 "five adverse event reports of allergic type reactions were received," according to a company spokesman. Soon after, Fresenius decided to "pause" in its use of Omontys, the spokesman said.
Once again, overall facts and figures are what we have known for some time now....Light has been shed on discussions between AFFY and FDA, but still no update on the cause of the deaths, which I believe is still under investigation ? This article just rehashes the known facts.
0.2% is not statsically significant event, but warrants a check of the conditions of the patients and how they were adminstered the drug. what checks were made before each application, what existing medication there using (and their general health).
the 0.2%, could have and mostly likley would suffered side effect with a palecbo. In fact palcebo ide effect migth even be greater, It is this slight doubt that needs to be put to rest.
Takeda and AFFY are being very shrewd to ensure their is no mark on teh compnay and are taking the right steps to ensure the drug is cleared.
Informative. Longs always ignore that FDA already required warning label and still tout the warning label as the FDA's solution to get O back on the market. Looks as if the O death rate for dialysis CKD patients more in line with PEARL studies which proved O was deadly medicine for healthier CKD patients. Longs will now be even more encouraged since they can probably load up with cheaper AFFY shares.
Give it up will you? Still .2% reaction and .02% nobody at this point has no idea what's causing the reaction and all you monkey clowns are talking about is the .2% percent reaction. Now,, what about the rest of that 24,990 or so patient who was fine? If it is Monty I guaranteed you crooks that at least half of those patient would be dead already. Why only .2%? Because Monty was and will not be the cause.
25,000 patients were administered O. How many does? If 4 each that is 100,000 doses of 0. The WSJ article offered nothing for either Longs or Shorts to hang their hat on. If O were really a flawed drug we would expect to see many thousands of allergic reactions and many many more fatalities.
Indeniably clear evidence that weasly CEO and CMO are CHICKENING OUT on every leve. These smooth talkers and slick salespeople have nothing to say to the WSJ? C'mon. If this does not tell you everything you need to know about these people and this company, then you have no business investing in biotech. Thank you.
Spend it how you want it Mr. Samaritan but you still failed to respond to my question.
If it is Monty would you and anyone here believe that more than .2% of those patient would have gotten the same result? Because it was not and won't be Monty.
Spin it how you wanted Greg but you nobody's getting my shares until AFFY back on market in a few months!!!
In some of Epogen's patients have the same reactions as described in the article. Their monitoring on patients are very strict. Such patients would be injected with an anti-hypersensitivity drug in all the cases. Patients live!
Omontys is a good drug but the monitoring precedure is poor and that's why FDA has not officially recalled the drug. The recall was voluntary!