AMAG: FDA Delays Feraheme Decision

AMAG Pharmaceuticals (AMAG) expects the U.S. Food and Drug Administration to make its approval decision on the company's iron replacement therapy Feraheme within the next few days, the company said Monday night.

The FDA's decision was supposed to come Monday but has been delayed for administrative reasons, said AMAG, based on the company's contact with the agency in recent days.

The FDA has not requested any additional information from AMAG and no outstanding issues remain regarding Feraheme, according to the company.

AMAG CEO Brian Pereira, on a Tuesday morning conference call, said the company was disappointed in the delay but that the company will be ready to launch Feraheme commercially within weeks of FDA approval.

Feraheme is an injectable iron replacement therapy that will be used to correct anemia in patients with chronic kidney disease.

But the FDA must approve Feraheme before it can be sold, so what does this latest delay mean for AMAG? Two possible scenarios: First, this latest delay is simply an administrative backlog at the FDA, per AMAG's assertion. It is taking longer than expected to get all the signatures and sign-offs necessary for Feraheme's full approval, so this latest, short delay is no big deal.

Second, the FDA does have a significant (and un-identified) problem with Feraheme's approval so the drug is now in regulatory limbo. A delay could stretch on for months, as has happened with Cardiome's (CRME) drug for atrial fibrillation.

The second scenario cannot be completely discounted, but it seems unlikely at this point, especially since AMAG resolved in April all the Feraheme manufacturing issues that had previously delayed the product's approval.

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