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Liver volume was reduced by a mean of 13.5 percent for patients initially treated with Kanuma and by 11.4 percent for patients initially treated with placebo. We are encouraged by these study results, which show marked and sustained improvements in disease-related lipid and liver abnormalities in patients with LAL-D who were treated with Kanuma and highlight the need for long-term therapy for patients with this devastating and life-threatening disease, said study investigator Katryn Furuya, M.D., Associate Professor of Pediatrics, Division of Pediatric Gastroenterology and Solid Organ Transplant, Mayo Clinic, Rochester, Minn. Importantly, results for patients who initially received placebo before switching to Kanuma mirrored those of patients who received Kanuma from the start of the double-blind period, suggesting a consistent and reproducible treatment effect across a large group of treated patients. The safety profile of Kanuma during the extended open-label period was consistent with that observed in the double-blind period. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity, and no patient discontinued the open-label study because of adverse events. The most common TEAEs in the open-label period were headache (40 percent), nasopharyngitis (35 percent), and cough (28 percent). Twelve patients (18 percent) experienced an infusion-associated reaction during the open-label period; all but one reaction were mild or moderate in intensity. Additional Data Presented at WCPGHAN Researchers are also presenting updated results from the ongoing, open-label, Phase 2/3 VITAL study of Kanuma in infant patients who presented with evidence of growth failure or rapidly progressive LAL-D within the first 6 months of life. go to my blogFindings were previously reported at the 12th Annual WORLDSymposium in March 2016, demonstrating that as of January 2016, 5 of 9 patients (56 percent) treated with Kanuma had survived beyond two years of age. navigate hereNew data being presented at WCPGHAN show that as of August 2016, 5 of 9 Kanuma-treated infants had survived beyond three years of age, with the oldest patient now more than five years old. All five patients continue to receive treatment.6 Alexion will also present information on the first global LAL-D registry, which aims to improve patient outcomes through a better understanding of the treatment and care of this ultra-rare disease.
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