Pfizer plans to launch its anti-infective Eraxis this spring for the treatment of esophageal candidiasis, candidemia, and other forms of Candida infection.

FDA issued a combined approval Feb. 17 for two Eraxis (anidulafungin) NDAs, one for esophageal candidiasis and another for invasive candidiasis/candidemia.

According to FDA, the new molecular entity is approved "to treat Candida infections in the esophagus (candidiasis), blood stream (candidemia), and other forms of Candida infections, including abdominal abscesses and peritonitis (inflammation of the lining of the abdominal cavity)."

In clinical trials, patients treated with intravenous Eraxis had improved efficacy versus those receiving Pfizer's Diflucan (fluconazole), the firm said; Eraxis was also shown to have a similar safety profile. Common adverse events included headache, mild diarrhea and slight increases in certain liver enzymes.

Pfizer obtained Eraxis through its $1.9 bil. acquisition of Vicuron in September 2005. The company also acquired anti-infective Zeven (dalbavancin) for the treatment of complicated skin and soft tissue infections, which it anticipates will gain FDA approval in the second quarter of this year following an "approvable" letter in September.

Pfizer called Eraxis the only product shown to have improved efficacy over Diflucan; the gold standard antifungal became available as a generic in 2004 (¹ Also see "Diflucan Generics Launch Following Expiration Of Pfizer Exclusivity" - Pink Sheet, 29 July, 2004.).

The company's other antifungal products include include Vfend (voriconazole) for the treatment of serious mold and yeast infections.

Vicuron originally submitted an NDA for both indications in 2003, but split the submissions following a May 2004 approvable letter. The firm received a second "approvable" letter in November 2005 for the esophageal candidiasis indication (² Also see "Pfizer “Approvable” Streak Continues With Second letter For Anidulafungin" - Pink Sheet, 5 December, 2005.).

FDA's recent approval coincides with the priority review action date for the invasive candidemia NDA, resubmitted Aug. 18.

-Mary Bruce

Pfizer To Spring Forward With Eraxis Launch

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