Lux files for Luveniq approval in U.S. and Europe

Backed by promising data from 450 patients in seven countries, Lux Biosciences has rapidly marched from the clinic to regulatory agencies in Europe and the U.S. with a marketing application for Luveniq--LX211--as a new treatment for non-infectious uveitis.

"The results seen in the Luminate clinical trial program, the largest completed to date in non-infectious uveitis, support our belief that LX211 has the potential to significantly advance the treatment of this blinding disease," says Ulrich Grau, Lux Biosciences' president and CEO. "This is the first regulatory filing of voclosporin in any indication, in any country, which made this submission a complex task. It incorporates the research and development undertaken by our collaboration partner Isotechnika over more than a decade, and that of Lux Biosciences over the last 3 ½ years. Simultaneous filings of both a U.S. New Drug Application and a European Marketing Authorization Application for LX211 represent a major milestone for Lux Biosciences."

I met with Grau at the J.P. Morgan healthcare conference in San Francisco, where he was brimming with confidence about Luveniq's chances with regulators, as well as the developer's long-term prospects. Grau has been laying the groundwork to recruit a small sales force to sell the drug in the U.S., but has been leaving open the possibility of signing a partner for the European market. He also made it clear that Lux, which is based in Jersey City, NJ, would have already filed for an IPO if the public markets hadn't been frozen shut all of last year. Lux completed a $50 million Series B last fall.

- here's the press release