Merck's new antibiotic hops on the FDA fast track

Merck ($MRK) has secured the FDA's fast-track designation for its latest antibiotic candidate, a mid-stage treatment for complicated infections. The drug, relebactam, works by inhibiting beta-lactamases, enzymes bacteria produce to protect themselves against common antibiotics. Merck is in the midst of Phase II trials studying its candidate as part of an anti-invective cocktail against complicated urinary tract infections and complicated intra-abdominal infections, planning to start late-stage study next year. With the FDA's fast-track status, Merck is guaranteed a shorter review time and ready access to agency experts. In addition, the FDA has tabbed relebactam as a Qualified Infectious Disease Product, which would grant the drug an additional 5 years of market exclusivity if it's approved. More