Actelion Pharmaceuticals US Inc. (ALIOF.PK) said the U.S. Food and Drug Administration or FDA approved their supplemental new drug application or sNDA for second generation VELETRI, for pulmonary arterial hypertension treatment to improve exercise capacity. The studies establishing effectiveness comprised predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
The company added that the second generation VELETRI would offer patients an expanded stability profile and prolonged storage capacity. Also, President of Actelion Pharmaceuticals US Inc., Shal Jacobovitz, noted that second generation VELETRI provides patients and their caregivers a treatment option that allows patients to have more flexibility in their daily lives.
Moreover, Actelion would make VELETRI available in 2 vial strengths, 0.5 mg and 1.5 mg, and it would be commercially available in the third quarter of 2012. The new 0.5 mg vial is recommended for patients using final concentrations of VELETRI < 15,000 ng/mL. Until the newly approved formulation and vial strength become available, patients should continue to use VELETRI according to the current package insert.
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by RTT Staff Writer
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