Pfizer's anti-infective anidulafungin received a second "approvable" letter Nov. 25 for the treatment of esophageal candidiasis, FDA said.

Pfizer obtained anidulafungin through its June acquisition of the biotech firm Vicuron.

Vicuron received an approvable letter in May 2004 for an earlier anidulafungin NDA, which included both the esophageal candidiasis indication and an invasive candidiasis/candidemia indication (¹ Also see "Vicuron Will Resubmit Anidulafungin For Invasive Candidiasis Under Separate NDA" - Pink Sheet, 21 September, 2004.).

In response to the first approvable letter, Vicuron divided the NDA into two separate applications. The esophageal candidiasis NDA had a user fee date of Nov. 27.

The firm submitted the NDA for invasive candidiasis/candidemia Aug. 18; under standard review, the application has a June 18, 2006 estimated user fee date (² Also see "Vicuron Submits NDA For Additional Anidulafungin Indication" - Pink Sheet, 18 August, 2005.).

The approvable letter for anidulafungin is the latest in a string of setbacks for Pfizer. The firm has received approval for several line extensions thus far in 2005, but FDA has not yet signed off on any novel agents.

Pfizer had to resubmit filings for its sleep agent indiplon; it received a user fee extension for its inhaled insulin Exubera due to the submission of additional technical data; and it received "not approvable" letters for its osteoporosis prevention agent Oporia (lasofoxifene) and its injectable COX-2 inhibitor parecoxib.

Pfizer's lipoglycopeptide antibiotic dalbavancin - also acquired through the Vicuron deal - received an approvable letter Sept. 21 for the treatment of chronic skin and soft tissue infections (³ Also see "Pfizer’s Dalbavancin “Approvable”" - Pink Sheet, 22 September, 2005.).

-Brian Marson

Pfizer “Approvable” Streak Continues With Second letter For Anidulafungin

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