The FDA agreed with the company’s conclusions regarding the clinical trial results and supported the approval of the drug. The FDA review, however, raised the issue of hypotension associated with the higher dose and recommended capping the dose at 1.5 mg three times a day since the higher dose did not appear to add an incremental benefit, Dr. Preston Dunmon, a medical officer in the FDA’s division of cardiovascular and renal drug products, told the panel. But panelists said that there should be a broad range of doses to choose from and that the 2.5 mg t.i.d. dose should be available.
Currently, there is no drug approved for treating CTEPH. Bosentan (Tracleer), an endothelin receptor antagonist, and sildenafil (Revatio), a PDE-5 inhbitor, are approved for PAH (WHO Group 1). The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts before the meeting.
If approved, Bayer plans to market the drug as Adempas.
The results of the two studies were published in the July 25 issue of the New England Journal of Medicine (PATENT-1 [369:330-40]; CHEST-1 [369:319-29]).