Nature Medicine | Spoonful of Medicine

Anemia drug recalled amid safety concerns in dialysis patients

Vials of Omontys

Affymax

After less than a year on the market, a long-acting anemia drug called Omontys (peginesatide), a once-monthly injection used by people with chronic kidney disease, was recalled over the weekend, after US regulators received 19 reports of severe allergic reactions, including some deaths. Shares of Affymax, the Palo Alto, California–based company behind the product, were down 85% today on the news.

Omontys was approved by the US Food and Drug Administration in March 2012 as an alternative to recombinant versions of the hormone erythropoietin, which signals the bone marrow to make more red blood cells, for individuals undergoing kidney dialysis. A synthetic peptide that activates erythropoietin receptors, Omontys offered several advantages over other erythropoietin-boosting options, including longer-lasting effects that reduced the frequency of injections. By comparison, the next longest lasting erythropoietin replacement drug available in the US, darbepoetin, marketed as Aranesp by California-based Amgen, requires biweekly injections (see ‘New blood-boosting drugs aim to staunch renal anemia’).

In clinical trials, Omontys showed no major safety concerns and was actually thought to shield patients from a rare complication of erythropoietin-based drugs in which antibodies develop that target the body’s endogenous hormones, effectively shutting down all blood cell production and exacerbating the anemia. Whereas neutralizing antibodies occurred in just a little over 1% of patients taking Omontys, it is not really known what caused the allergic reactions that led to the recall. “These adverse reactions were not described in the clinical trials for the dialysis patients, and I do not recollect any such responses reported,” says Jeffrey Berns, a nephrologist at the University of Pennsylvania Perelman School of Medicine in Philadelphia, who was a member of the data and safety monitoring board for Omontys.

Although people who took Omontys need to remain vigilant, Berns doesn’t think the product recall should greatly interrupt their therapy. “Since there are other widely utilized alternatives, this [recall] should not adversely affect the patients who are on dialysis because they will be able to use one of the other available agents,” he says. More disturbing to drug companies, Omontys’ recall may setback the development of other peptide-based analogs, according to Berns. “It should prompt closer scrutiny if other peptide-based agents come to clinical trial.”

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    Christopher Lee said:

    It isn’t quite clear from the article whether the adverse reaction was attributed to the drug substance or to an impurity that was not present in the batches used for the clinical trials.