The letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work. If the company does need to conduct further clinical trials this may constitute a significant delay in the drugs path to market.
“We will work in close collaboration with the FDA to clarify the path forward. We are hopeful that this can be accomplished without the need for additional clinical work, but that will require discussion with the agency before we can be sure,” said Dr Bruce Given, president and CEO of Encysive Pharmaceuticals. “We remain confident in Thelin’s value, and look forward to the opportunity to provide PAH patients with a new treatment option.”
Pulmonary arterial hypertension (PAH) is characterized by symptoms including shortness of breath, fatigue, and angina caused by a lack of oxygen to the heart muscle. The disease causes the heart to work harder and can lead to heart failure.