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AMAG’s Feraheme Gets Approval, So Does This Answer Our Question About the FDA?

June 30, 2009 at 8:39 pm EST | Tags: Drugs, FDA, Filings & Approvals, Healthcare & Medicine

AMAG's Feraheme Gets Approval, So Does This Answer Our Question About the FDA? First of all, congrats to AMAG Pharmaceuticals (AMAG). The company has been at it for a long time and to get any drug approved in today’s regulatory environment is a great accomplishment. AMAG’s drug, feromoxytol (Feraheme), which won FDA approval today, is designed to treat adult patients with iron deficiency anemia with chronic kidney disease (CKD). AMAG says the drug, which is given intravenously, should be available during the second half of July.

AMAG still faces the hurdle of getting the drug reimbursed and bringing in revenue. With the current administration and healthcare reform movements undeway, this could pose some challenges. Feraheme, however, does have advantages over its two competitors, Venofer and Ferrlecit, so we’ll see how things go.

The news sent AMAG shares up 4% to $56.90 in after-hours trading.

As for our earlier question about what’s going on at the FDA, maybe it was kinda’ answered today. The agency missed the Feraheme PDUFA yesterday, but AMAG said it “expected (the FDA) to issue an action letter ‘within the next few days.’ “

And, the answer came.

So, does this mean that the FDA is not backed up? HEB, BDSI and ACUR all received similar “letters” from the FDA, but yet didn’t get a complete response. Today’s AMAG news makes it look like the agency knew a Feraheme approval was coming, but somehow needed “more time” for these other NDAs (Onsolis, Acurox, Ampligen). So again, we ask…

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Comments

One Response to “AMAG’s Feraheme Gets Approval, So Does This Answer Our Question About the FDA?”

yellowshoes44 says:

July 1, 2009 at 10:52 am

What is going on? This delay with HEB is getting to be more than absolutely ridiculous. How does a company let 1-2 weeks pass after the proposed PDUFA date and then let another 1-2 weeks pass without contacting the FDA. The FDA was established to serve the people and in “doing so” their should be clear communication. A government agency, especially one that has such a huge effect on the health of so many, should not be allowed to miss dates and step to the side and act like they can finish, if they ever do, when they want to finish. I think it is time for Hemispherx to contact the FDA and request information on what is happening because this situation is unfair to the investors of HEB and most importantly those who suffer from CFS/ME. I believe 100% that this drug will get approved but it is not right for Hemispherx to sit back and let their investors and CFS hopefuls take the hit because of a lack of communication.