Acucela Gets FDA Fast Track

Acucela and its partner, Japan-based Otsuka Pharmaceutical, said today they have received “Fast Track” designation for an application to market a new drug for the “dry” form of age-related macular degeneration. The designation means that the companies will  be able to file data on their drug,  ACU-4429, as it becomes available, and which makes it possible for the companies to get a faster-than-usual six-month review that is sometimes given to applications to treat serious or life-threatening conditions.

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.