European Medicines Agency Grants Accelerated Assessment of Marketing Authorization Application for Xilonix™, XBiotech’s True Human™ Therapeutic Antibody Treatment for Advanced Colorectal Cancer

XBiotech Inc. (NASDAQ:XBIT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated review for Marketing Authorization of Xilonix, the Company’s first-in-class True Human monoclonal (IgG1k) antibody treatment for advanced colorectal cancer. The CHMP grants accelerated review for medicines deemed to be of public health importance and that represent therapeutic innovation. The accelerated review procedure allows the CHMP to grant an opinion two months earlier than the normal 210-day procedure. With this action, a decision on Xilonix’s approval could come as early as third quarter 2016.
According to the news:

XBiotech recently received validation of its Marketing Authorization Application (MAA) for Xilonix based on results of a Phase III study, which showed a 76% relative improvement in response rate in patients treated with the antibody, as compared to placebo (p=0.0045). Patients treated in the Phase III study had colorectal tumors that were metastatic or inoperable, had failed all recommended forms of chemotherapy and most other forms of therapy, and suffered from symptoms including pain, fatigue, anorexia and wasting. The patients treated in the Phase III study were considered to represent a large patient population that is physically and emotionally exhausted from the disease and treatment-related toxicities.

John Simard, Chairman, Chief Executive and founder of XBiotech commented:

XBiotech is encouraged by CHMP’s action to grant accelerated review of Xilonix. There is an urgency to provide advanced colorectal cancer patients with access to new treatments that have been developed with their specific needs in mind.