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

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.