The FDA is set to give the Medivation/Astellas drug enzalutamide the once-over on November 22. The daily medication is for castration-resistant prostate cancer for patients who have previously undergone docetaxel-based chemotherapy. The FDA accepted the new drug application under a priority review designation.
Teva is kicking off a third Phase III trial of experimental relapsing MS drug, laquinimod, the firm said. The company, along with partner Active Biotech, said in a statement Wednesday that the daily oral medication will be tested in a 24-month trial of about 1,800 patients. The trial will be used to test a 0.6-mg dose and a 1.2-mg dose. An oral treatment could be a big deal in the space, for injections and infusions are the most common forms of medical treatments for the degenerative disease of the central nervous system. But Teva’s R&D program trails other players, including Biogen Idec’s BG-12, now awaiting FDA approval, and Novartis’ Gilenya, which has had a slow launch. The new Phase III trial, CONCERTO, follows the completed ALLEGRO and BRAVO Phase III studies. Laquinimod is also in Phase II tests for treating Crohn’s disease and lupus.
