FDA Grants Expanded Label for Ventavis
SOUTH SAN FRANCISCO, Calif., August 30, 2005 -- CoTherix, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to modify the Ventavis (iloprost) Inhalation Solution label to include: 1) information from the Company’s clinical study evaluating the safety of Ventavis used in combination with Actelion’s Tracleer (bosentan) for pulmonary arterial hypertension (PAH); and 2) the use of Respironics, Inc.’s portable, hand-held I-neb(TM) AAD(R) device for the delivery of Ventavis pending receipt of 510(k) regulatory clearance.
The changes to the label were based on the Company’s two sNDA (supplemental New Drug Application) filings submitted in April 2005. The first included information from the Company’s STEP Trial (acronym for: iloprost inhalation solution Safety and pilot efficacy Trial in combination with bosentan for Evaluation in Pulmonary arterial hypertension). The new label describes the safe use of Ventavis in combination with Tracleer, an oral endothelin receptor antagonist, for PAH. The second sNDA included results to allow information regarding the use of the I-neb device to be included in the Ventavis label.
"We are pleased that our label now addresses the use of Ventavis in combination with Tracleer. We believe this advances the current trend toward combination therapy in the management of PAH," said Thomas L. Feldman, President and Chief Business Officer of CoTherix, Inc. "We are especially delighted with the rapid execution of our clinical and regulatory strategy for the label modifications, with the approval coming only 14 months after initiating the STEP Trial and four months after submitting the sNDA’s."
Feldman added, "Based on today’s announcement, we expect to begin the initial roll out of the I-neb to patients by the end of the year."
Full data from the STEP Trial will be presented by Dr. Vallerie McLaughlin, M.D., Associate Professor of Medicine and Director of the Pulmonary Hypertension Program, University of Michigan, at the of Chest Physicians meeting in Montreal on October 31, 2005.
About the STEP Trial
The STEP Trial was a double-blind, placebo-controlled trial, in which PAH patients treated with Tracleer, an oral endothelin receptor antagonist, were randomized to receive either Ventavis (inhaled iloprost) or inhaled placebo in combination with Tracleer for 12 weeks. Fifteen U.S. clinical sites enrolled 65 patients into the intent-to-treat analysis population (32 Ventavis and 33 placebo). Baseline characteristics were well-balanced across the two arms. Compliance with scheduled doses was over 90% in each arm, with the majority of patients taking six inhalations per day.
Source: CoTherix, Inc.
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