Injectafar gets FDA non-approvable letter

Swiss pharmaceutical firm Galencia says that the US Food and Drug Administration has issued a non-approvable letter regarding its candidate iron replacement therapy Injectafar (ferric carboxymaltose for injection). The FDA cited concerns about the product's risk/benefit profile as a treatment for anemia in women with post-natal depression or those suffering from heavy uterine bleeding.

Galencia said in the letter, which was first received by partner Luitpold Pharmaceuticals, the FDA has requested more data to "better characterize the mortality safety signal" detected in previous studies. The Swiss firm added that this was in contrast with a February 1 meeting at which it said that an agency panel had voted that the data did support its safety.

Injectafar has been registered under the name Ferinject in 18 European Union countries, and is already available as a treatment for iron deficiency in Germany and Switzerland.