Biotech firm Sequella has been granted Fast Track designation from the U.S. Food and Drug Administration on a tuberculosis drug currently in the Rockville-based company’s pipeline. The designation, which means the FDA will give priority to the drug when reviewing approval applications, could shave several years off Sequella’s timeline for getting the drug to market.
Sequella’s SQ109, which is still in Phase I clinical trials, could replace several of the drugs on the market to treat the illness. Many of the available drug treatments for TB haven’t been updated in more than 30 years.
Sequella’s drug is still a few years from reaching Phase III trials, said Gary Horwith, Sequella’s chief medical officer.
It is estimated that 9 million people were infected with the respiratory disease and 2 million people died from the illness worldwide in 2002, with many of those cases in developing countries.
But because many TB sufferers are not in the U.S. “it’s not a particularly attractive area for drug development,” Horwith said.
Sequella has seized on that market opening and has a fewTB-focused products under development. The firm recently announced a partnership with PATH, a global health organization, to test its TB diagnostic test on humans in Ukraine. That product is expected to be available overseas within the next six to nine months.
