FDA approves Adcirca (tadalafil) tablets for pulmonary arterial hypertension

Published on May 26, 2009 at 5:40 AM · No Comments

United Therapeutics Corporation announced today 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.

"Today, 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, Ph.D., 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, Ph.D., United Therapeutics' President and Chief Operating Officer.

Conference Call

United Therapeutics will host a half-hour teleconference today, May 26, 2009, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 877-857-6147, with international callers dialing 719-325-4797. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 888-203-1112, with international callers dialing 719-457-0820, and using passcode: 2104929.

This teleconference is also being webcast and can be accessed via United Therapeutics' website at http://ir.unither.com/events.cfm.

About Adcirca

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 licensed the rights to develop, market, promote and commercialize Adcirca for pulmonary hypertension in the United States and Puerto Rico from Eli Lilly & Company in November 2008. Adcirca contains the same active ingredient as CIALIS (tadalafil), which is marketed by Eli Lilly & Company to treat erectile dysfunction (impotence) in more than 100 countries.

Safety Information for Adcirca

Adcirca should not be used in patients taking medicines that contain nitrates (often used for chest pain) as the combination could cause a sudden, unsafe drop in blood pressure. If a patient experiences anginal chest pain after taking Adcirca they should seek immediate medical attention. Patients with a known serious hypersensitivity to tadalafil (Adcirca or CIALIS) should not take Adcirca.

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