Monday, July 13, 2009
Bilastine is a new antihistamine that is being investigated around the world. Bilastine will be taken orally for allergic rhinitis and in eye drops for allergic conjunctivitis. Bilastine has been approved in a few European countries. However, bilastine is not approved for use in the U.S. yet. The manufacturer, Faes Farma, has partnered with Inspire Pharmaceuticals in the U.S. The FDA has required additional studies to determine if bilastine has any adverse effects on the heart, specifically lengthening of the QT interval. No word on the status of these studies. I expect this process could take two years, before approval in the U.S. and then additional delay as marketing and production gears up.