TG Therapeutics Obtains Special Protocol Assessment From FDA

TG Therapeutics said Tuesday it reached an agreement with the US Food and Drug Administration regarding a special protocol assessment on the design of two phase 3 clinical trials for ublituximab, the company’s antibody to treat relapsing forms of multiple sclerosis. The assessment provides agreement that the two phase 3 trial designs adequately address objectives that, if met, would support the regulatory submission for approval of ublituximab.

TG Therapeutics said about 880 patient will be enrolled in the phase 3 trials, which are slated to run for 96 weeks. The company said it expected the phase 3 program to establish ublituximab “as an important new drug in the treatment of MS.”

By Bryan Smith