Affymax, Takeda recall anemia drug Omontys following severe allergies, deaths
Palo Alto, CA, United States (4E) – Pharmaceutical firms Affymax Inc. and Takeda Pharmaceutical Co. said they ordered a recall of their anemia drug Omontys following reports of allergic reactions with kidney-disease patients, including a few cases of deaths.
In addition to the recall, health professionals have been told not to prescribe the drug, which is sold in 10 and 20 milligram vials, according to a statement released by the companies.
The pharmaceutical firms also said that the recall has received approval from the U.S. Food and Drug Administration, which also approved Omontys in March last year.
The recall is a huge blow to Affymax since the Palo Alto, Calif.-based small biotechnology firm has no other drugs in its pipeline that are in the late stages of development.
The move will also affect many kidney-disease patients that have been receiving the drug because it is a cheaper and more convenient alternative to Epogen, Amgen Inc.’s blockbuster drug that holds a near-monopoly of the anemia treatment market.
Around 25,000 patients have received treatment with Omontys, according to data released by Affymax on Saturday. The data also showed that five patients have died after being treated with the drug, while 17 others suffered severe allergic reactions that required medical help or hospitalization. The reactions reportedly occur 30 minutes after taking the first dose.
Symphony Health’s data shows that sales of Omontys grew three times in January to $19mn.