United Therapeutics Corporation announced that the United States Food and Drug Administration (FDA) has approved Adcirca (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). Adcirca is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.
"Thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an effective, convenient and economical therapy for PAH patients," said Martine Rothblatt, United Therapeutics' chairman and chief executive officer. "The FDA's action in approving once-a-day Adcirca is a big plus for all three P's: patients, physicians and payors."
In the Phirst-1 randomized, double-blind, 16-week placebo-controlled phase-3 clinical trial of Adcirca for PAH, patients taking Adcirca 40 mg (administered as two 20 mg tablets) once daily achieved a 33 meter improvement in six-minute walk distance compared to the placebo group. In addition, Phirst-1 patients taking Adcirca 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group. The most common adverse events in the trial were generally transient, mild to moderate in intensity and included headache, muscle pain, flushing, nasopharyngitis, respiratory tract infection, nausea, pain in the arms, legs or back, upset stomach and nasal congestion.
"Our dedicated team at United Therapeutics looks forward to working closely with the PAH community as we prepare to launch Adcirca in the United States at the beginning of August this year," said Roger Jeffs, United Therapeutics' president and chief operating officer.
Adcirca is a prescription medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature.
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer.