United Theraputics revokes application to EMA for hypertension drug
United Therapeutics has withdrawn its marketing authorization application to the European Medicines Agency (EMA) for the approval of treprostinil sodium (Tyvaso) after the Committee for Medicinal Products for Human Use (CHMP) said that the drug was non-compliant with clinical practice.
Tyvaso, used to treat pulmonary arterial hypertension (PAH) and administered in a 0.6 mg/ml nebulizer solution,was found to be non-compliant at two of its clinical test sites.
"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," said Roger Jeffs, PhD, president and COO of United Therapeutics.
United Therapeutics said this objection by the CHMP for compliancy would prevent its recommendation by the EMA for the drug to be marketed throughout Europe and withdrew its application.
Tyvaso, used to treat pulmonary arterial hypertension (PAH) and administered in a 0.6 mg/ml nebulizer solution,was found to be non-compliant at two of its clinical test sites.
"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," said Roger Jeffs, PhD, president and COO of United Therapeutics.
United Therapeutics said this objection by the CHMP for compliancy would prevent its recommendation by the EMA for the drug to be marketed throughout Europe and withdrew its application.