FDANews

Accentia Announces Investigational New Drug Application for Revimmune

Accentia Biopharmaceuticals has met with the FDA for a scheduled pre-investigational new drug meeting on Revimmune, the company’s potential therapeutic for refractory relapsing-remitting multiple sclerosis (MS).

The FDA has indicated support for Accentia’s submitting an investigational new drug application for a pivotal Phase III trial of Revimmune, Accentia said.

The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability with disability at month 12 with an interim data analysis. The company expects to commence the study in the first half of 2008.