Schering-Plough's Noxafil (posaconazole) oral suspension cleared FDA for the treatment of oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole, the company announced Oct. 23.

The approval comes just over one month after FDA approved Noxafil for prophylaxis of invasive Aspergillus and Candida infections in patients 12 years of age and older who are at high risk of developing these infections due to being severely immunocompromised. Noxafil is the first antifungal approved by FDA for Aspergillus infections (¹ Also see "Noxafil Is First FDA-Approved Antifungal For Aspergillus Infection Prevention" - Pink Sheet, 19 September, 2006.).

The company submitted separate NDAs for the indications in February, with FDA granting a priority review for fungal infections and a standard review for OPC (² Also see "Schering Antifungal Noxafil Gets Priority Review For Prophylactic Use" - Pink Sheet, 22 February, 2006.).

OPC is a fungal infection of the mouth and throat caused by the yeast Candida.

The latest approval is based on results of a randomized, controlled, evaluator-blinded study in HIV-infected patients comparing Noxafil to fluconazole, as well as a non-comparative study of Noxafil in HIV-infected patients with OPC that was refractory to treatment with fluconazole or intraconazole, according to Schering.

The European Union's Committee for Medicinal Products for Human Use recommended approval of Noxafil for both indications to the European Medicines Agency in September. That application is currently pending a final European Commission decision.

During Schering-Plough's third quarter sales and earnings release Oct. 20, Exec VP & President-Global Pharmaceuticals Carrie Cox noted that the approval of the antifungal in the U.S. and EU will result in approximately 200,000 patients per year who may be eligible for Noxafil therapy.

"While the market size may be modest, the benefit of Noxafil to patients can be enormous," she said. "We are quite proud to be associated with such an important life saving medicine."

-Jessica Merrill (j.merrill@elsevier.com)

Noxafil Gains Additional Oropharyngeal Candidiasis Indication

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