GlaxoSmithKline has opted to cease pursuit of approval for its antiemetic Rezonic/Zunrisa (casopitant), and is pulling all ongoing marketing applications. "After regulatory consultation," the firm explained, its assessment was that "significant further safety data would be required to support the registration of casopitant on a worldwide basis, which would take considerable time to produce." GSK had been pursuing a set of indications that would have been an attractive commercial package: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly and moderately emetogenic chemotherapy, and prevention of postoperative nausea and vomiting. The drug had been slated for FDA advisory committee review in May, but the meeting was cancelled. In June, FDA issued a "complete response" letter for the application. The European Medicines Agency will make further details available following the Oct. 19-22 meeting of the Committee for Medicinal Products for Human Use. The NK-1 antagonist was a novel mechanism for the antiemetic field, and would have retained an oncology supportive care foothold to account for the loss of GSK's Zofran (ondansetron) to generic competition
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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