CAMBRIDGE, Mass., Dec. 15 (UPI) -- Irish firm Elan and U.S. drug maker Biogen Idec said Friday they are seeking approval of multiple-sclerosis drug Tysabri for Crohn's disease.
The companies said they submitted data from three placebo-based clinical trials: ENCORE, to test how well the drug works in Crohn's disease response and remission; ENACT-1, to assess the treatment as active Crohn's therapy; and ENACT-2, to test Tysabri as a continuous Crohn's treatment.
The firms added they have also included in the submission proposed labeling and a risk-management plan, both of which are similar to those approved for the MS indication.
Tysabri stirred controversy in 2005 when three MS patients using the drug developed a rare brain disorder known as PML, resulting in the treatment's temporary suspension from the market, pending further safety studies.
Last June the Food and Drug Administration OK'd Tysabri's return to market to treat relapsing forms of MS with the stipulation that it be used only as a monotherapy and not in conjunction with other MS treatments.
