Masitinib regulatory update

AB Science said FDA approved an IND for compassionate use of masitinib in 1 patient with amyotrophic lateral sclerosis. The company is evaluating masitinib in the double-blind, European Phase II/III Study AB10015 to treat ALS (see BioCentury, April 18). AB Science said EMA’s rapporteurs recommended the company submit an MAA seeking conditional approval of the product in combination with riluzole to treat adults with ALS (see BioCentury, June 13). AB Science expects to submit the application by the end of 3Q16. ...