New Shire drug significantly reduces HAE attacks
Shire says trial shows new HAE drug significantly reduces attacks
LONDON (Reuters) – London-listed drugmaker Shire said on Monday it had successfully tested a new medicine that prevents attacks in patients with hereditary angioedema (HAE), a rare genetic disease that causes swelling of extremities, the gastrointestinal tract and upper airways.
The company said the drug, referred to as SHP616 and administered every three to fours days by injection, reduced rates of attack by 85 percent after 14 days compared with a placebo, meeting its primary and secondary endpoints.
It said 38 percent of patients in the late-stage trial were completely free of attacks in the 14 weeks when they were taking SHP616, compared with 9 percent in the period when they were using a placebo.
“We are very pleased with the strong results of this study, which demonstrated efficacy with a low-volume dosing regimen, and what it potentially could mean for the global HAE community, if approved,” said Shire’s head of research and development, Howard Mayer.
Reporting by Paul Sandle; Editing by Greg Mahlich