Patients with inflammatory bowel disease may soon have another weapon at their disposal to manage and treat their condition.
The biologic agent vedolizumab has won recommendations from an FDA advisory panel for the treatment of Crohn's disease (CD) and ulcerative colitis. The data reviewed shows that the agent works better at treating ulcerative colitis and is less effective on CD. However, certain panel members did note some efficacy for CD patients who did not respond to other treatment options. Both ulcerative colitis and CD are inflammatory bowel diseases affecting the digestive tract.
The FDA committee votes, sees benefits outweighing risks
Takeda Pharmaceuticals (NASDAQOTH: TKPYY ) , the drug's manufacturer, submitted vedolizumab, or VDZ, for FDA review. The panel was asked to approve whether the benefits outweigh the risks of using VDZ for patients that fell into three "failed treatment" buckets – patients that failed steroids, immunosuppressants, or TNF blockers; patients that failed immunosuppressants or TNF blockers; or patients who fall into neither category.
The trial results for ulcerative colitis showed the efficacy of VDZ as a primary and maintenance therapy. A majority of panel members voted in favor of recommending VDZ for ulcerative colitis patients that failed any of the three treatments .
The results of using VDZ for CD were less promising – only one trial achieved clinical remission at week 52. The second trial did not meet the expected remission at week six. According to one of the panel members, the expectations under the second trial were unreasonable and additional testing by the company could delay the drug's availability by about 10 years. As a result, a majority voted in favor of recommending vedolizumab for CD patients who have failed any of the three treatments .
Takeda also noted a low probability of patients developing PML, a potentially lethal brain infection. All 21 panelists agreed that the company had sufficiently accounted for the risk of PML to support approval of VDZ. Takeda has also agreed to conduct additional research and include a warning on the drug's packaging of the risk of PML despite no cases of PML occurring during the trials .
The drug's indication states the agent should be used for the purpose of treating moderate to severe cases of CD and ulcerative colitis in patients that do not respond or tolerate other therapies such as tumor necrosis factor (TNF) blockers. Some TNF blockers on the market include Humira, manufactured by AbbVie (NYSE: ABBV ) , and Cimzia, made by UCB SA (NASDAQOTH: UCBJY). Both Humira and Cimzia block swelling and pain caused by CD . As patients experience a reduced response to current treatments, a new drug like VDZ can treat patients that have run out of options.
Vedolizumab is part of innovative therapies in Takeda's Vision 2020
Vedolizumab is expected to become a core product for Takeda Pharmaceuticals. The company has laid out a plan of where the company needs to be by 2020. Its R&D spending is being directed toward unmet medical needs within its core therapeutic areas, like "General Medicine." This category is responsible for the development of vedolizumab, as well as drugs for other conditions like peptic ulcers and acid reflux disease .
For fiscal 2013, Takeda spent about $3.45 million on R&D expenses, an increase of 15% over 2012 and approximately 21% of 2013 net sales. Fiscal 2013 net sales were up 5.3% to $16.57 million .
TNF blockers continue their successful run
Despite their intolerance by some patients, TNF blockers are widely used. Abbvie's Humira has become a blockbuster drug for the company. The company's third quarter worldwide sales of $4.66 billion increased 3.3% driven by the Humira's continued strength in the market. The drug's global sales rose 19% and U.S. sales alone grew 22.3%. Abbvie spent 15.2% of third quarter sales on R&D expenses that totaled $714 million. Part of the research conducted involved the pursuit of additional indications for Humira .
Cimzia provided similar results for UCB. Sales of the drug rose 27% during the first nine months of 2013. During the period, the drug was approved for additional indications and patients with certain types of arthritis now have access to the drug. Cimzia, along with epilepsy drug Vimpat and Parkinson's disease drug Neupro, offset some of UCB's decline in revenue due to the loss of exclusivity from its more mature products. For the first nine months, revenue decline 3% .
My Foolish conclusion
The market for treatment of irritable bowel disease will more than welcome another treatment option for patients who need to manage their condition and may not have found relief with current treatments. These issues tend to be chronic, so a lifetime of care is usually needed and they carry an overall health care cost of over $1.7 billion . For Takeda, the FDA approval of vedolizumab could bring long-term growth to the company and relief to millions that suffer from ulcerative colitis and CD.
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