Data about Takeda’s Phase III ulcerative colitis/Crohn’s disease medication indicate the drug could join the treatment mix that includes brand such as AbbVie’s Humira, Johnson & Johnson’s Remicade and UCB’s Cimzia.
The company announced the results of the two Phase III trials Wednesday, and published the findings Thursday in the New England Journal of Medicine. Takeda put the drug up for FDA review in June.
The studies showed ulcerative colitis patients had an improved clinical response within six weeks, compared to placebo and clinical remission at 52 weeks. Additional benefits included mucosal healing. Crohn’s Disease patients had statistically significant improvement at six weeks. The clinical trial used patients who had failed on other medications. While not unusual, Bloomberg points out that this patient subset is significant because around 10% of patients with these conditions, which are included in the category known as Irritable Bowel Syndrome or Irritable Bowel Disease, need to switch medications because the prescriptions stop working. Even with Humira in its pocket, AbbVie continues to seek new treatments, and recently extended its Crohn’s disease collaboration with Galapagos, to push exploration of GLPG0634 treatment into Phase II testing.
The roster of treatments for Crohn’s and ulcerative colitis are almost indistinguishable, and the financial benefits follow similar trajectories: AbbVie’s Humira has been enough of a blockbuster to carry its being spun-off from Abbott this year. Its list of approved indications includes Crohn’s, ulcerative colitis, rheumatoid arthritis, plaque psoriasis and psoriatic arthritis, among others, and earned the company $2.6 billion in sales for the first six months of the year. Johnson & Johnson’s Remicade’s list of approved uses mirrors those of AbbVie’s, and earned the drug maker almost $5 billion in sales for the first six months of the year.
