ZURICH Feb 27 Actelion Ltd, Europe's
biggest biotech company, said on Thursday that the U.S. health
regulator has granted fast-track status to its antibiotic
treatment for diarrhoea.
A fast track designation by the U.S. Food and Drug
Administration (FDA) speeds up regulatory review of drugs that
aim to treat serious diseases and fill unmet medical needs.
Actelion said the FDA was also designating Cadazolid as a
treatment for infectious diseases, which means the drug would
get a nine-month priority review if it completes current
late-stage trials successfully.
Actelion, which is trying to reduce its reliance on its
flagship drug Tracleer, received good news at the end of last
year, after regulators in Europe and the United States approved
Opsumit, a treatment for pulmonary arterial hypertension (PAH).