Keryx scored another victory on their flagship drug (ferric citrate) by garnering approval by the FDA for the trade name “Auryxia.” From this point forward, Keryx will market ferric citrate under the approved name, Auryxia. Investors were somewhat concerned when the FDA disapproved the name “Zerenex” at the same time the drug received approval on Sep 5, 2014. Shortly after their drug approval, Keryx stock declined rapidly on concerns that doctors would be required to now monitor iron stores in patients. Keryx quickly countered that argument by stating that doctors were already monitoring iron levels in their patients and taking ferric citrate wouldn’t change that routine in patients on dialysis with chronic kidney disease (CKD); their target customers.
Keryx has already received approval in Japan and is now looking for approval by the EMA in Europe, which they expect by the middle of next year. Auryxia won’t be cheap, but will be priced similary to the leading drugs that are currently serving the phosphate binder market (right around $500/month.) Auryxia not only addresses phosphate binding, but it also improves iron absorption by their patients; a problem currently being solved intravenously with injected iron. Auryxia shifts the costs of IV iron (now being paid by the dialysis clinics) to the insurance providers because dialysis clinics aren’t required to pay for drugs patients receive at the pharmacy. This puts Auryxia in a class of its own with economic advantages to the dialysis providers.
We’d like to congratulate Keryx on achieving this incredible milestone with the FDA. Welcome to the market Auryxia!