ZURICH (Reuters) - 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 diarrhea.
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).
Reporting By Katharina Bart; Editing by Noah Barkin