United Therapeutics pulls Tyvaso application in Europe because of testing site issues

United Therapeutics pulls Tyvaso application

SILVER SPRING, Md. — United Therapeutics Corp. said Friday it is withdrawing a European application for its hypertension treatment Tyvaso citing an objection by regulators over clinical practices at testing sites.

The company said the Committee for Medicinal Products for Human Use of the European Medicines Agency cited noncompliance at testing cites. The issue would preclude a recommendation for approval.

United Therapeutics submitted its application for approval in December of 2008.

The company said its revenue growth targets are unaffected by the move to withdraw the drug application in Europe. Tyvaso is approved in the U.S. It is inhaled drug intended to treat pulmonary arterial hypertension.