The FDA has granted Fast Track designation to Biota Pharmaceuticals Inc’s antiviral compound, BTA585, for the treatment of respiratory syncytial virus (RSV) infections in infants, young children and adults. The FDA Fast Track process is designed to expedite the development and review of drugs used in the treatment of serious or life-threatening conditions and which demonstrate potential to address unmet medical needs.
“There are no direct antiviral products approved to treat the millions of RSV infections that occur each year in the US and we are pleased that the FDA has recognized BTA585 and its potential to address this significant unmet medical need,” remarked Joseph Patti, PhD, president and chief executive officer at Biota. “Fast Track designation is another positive step for BTA585 and its development for the treatment of respiratory infections in children and adults.”
BTA585 is an oral RSV fusion inhibitor in development for the treatment and prevention of RSV infections. BTA585 has successfully completed a Phase 1 single ascending dose trial and has recently completed dosing in a multiple ascending dose trial with results expected to be reported this quarter. A Phase 2 RSV challenge trial is expected to begin in the second quarter of 2016.