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news.United Therapeutics has withdrawn its marketing authorisation application (MAA) for Tyvaso (treprostinil sodium) 0.6mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the EU.
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The MAA was withdrawn following communication from the Committee for Medicinal Products for Human Use (CHMP) of the EMA citing a major objection. The major objection noted that findings of non-compliance with good clinical practices (GCP) at two clinical sites would preclude a recommendation by the EMA for approval of the MAA for Tyvaso.
Roger Jeffs, president and chief operating officer of United Therapeutics, said: “Notwithstanding the fact that the EMA’s major objection noted findings of non-compliance with good clinical practices, it is important to note that there were no major objections related to the safety or efficacy of Tyvaso.”
Reportedly, United Therapeutics has submitted its MAA for Tyvaso to the European Medicines Agency (EMA) in December 2008. The data included in the MAA is based upon clinical work performed from 2005 to 2007 by United Therapeutics’ wholly-owned subsidiary Lung Rx.