Orphan Therapeutics has initiated a rolling NDA with the FDA seeking marketing approval for Lucassin for the treatment of hepatorenal syndromeType 1. Lucassin has been granted the orphan drug status and fast-track designation.
Following marketing approval of Lucassin, Orphan Therapeutics will transfer North American rights to Ikaria, which will then be responsible for its post-market development and commercialization.
Daniel Tasse, president and CEO of Ikaria, said: “The acquisition of Lucassin reinforces our corporate mission to deliver novel treatments in areas of unmet medical need within the underserved critical care market. We look forward to working with Orphan Therapeutics to provide a promising therapy to patients with this life-threatening condition.”