AMAG's Shares Drop As FDA Rejects Feraheme For Wider Use
In a recent communication AMAG Pharmaceuticals Inc., stated that the FDA recently denied their request to utilize their Feraheme drug on a broader scale; a medication used to treat iron deficiency anemia. According to the FDA, concerns have arisen regarding the safety of the product, and they have requested that the company compile and provide additional trial data to back up their claims. So far the industry has reported that the denial has resulted in a 15 percent drop in shares for the company.
The FDA issued a complete letter in response to AMAG’s application, and stated that in addition to compiling more trial data, the drug’s dosage recommendation should be reevaluated and a drug trial conducted on a wider population. In response, William Heiden, Chief Executive of AMAG stated, "We do have existing safety data from our two large late-stage trials ... certainly we would look to that data to support the safety profile of Feraheme."
Part of the additional data requested by the FDA related to safety information regarding hypersensitivity, cardiovascular events and deaths. Heiden also made a statement declaring that the company could begin a new trial focused on the safety of the product before its efficacy this year, should the FDA agree to this. He added that conducting the trial would be fairly easy and that, "The treatment period is fairly short and there's a fairly short follow-up." "The size of the trial and enrollment would be the determining factor on how long the trial would run."
This latest FDA rejection for Feraheme is just another one of the various issues the company has had with the drug in the past. The product is sold under the name Rienso in Europe and in May 2013, Takeda Pharmaceutical Co Ltd, one of AMAG’s partners, had to recall a large batch of the drug due to unexpected onsets of hypersensitivity and death.
Currently Feraheme is approved for the treatment of adult iron deficiency in patients with chronic kidney disease. However, the FDA refused to approve the drug for use in the treatment of patients with adult iron deficiency, who cannot tolerate traditional oral iron treatments; stating that there was not enough data to warrant the labeling of the drug as safe for these patients.
Source: http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=1892526&highlight