Encysive Pharmaceuticals Inc. launched Thelin (sitaxentan sodium) 100 mg tablets in Belgium and Luxembourg for the treatment of pulmonary arterial hypertension (PAH).
Encysive received European Union (EU) marketing authorization for Thelin from the European Commission in August 2006. Thelin is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment commercially available for PAH patients in the EU.
Thelin is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease (CTD).
The European Commission's centralized licensing procedure permits Encysive to market Thelin in all 27 member states of the EU. Thelin has already been launched in the United Kingdom, Germany, Ireland, Spain, France, Italy and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained, the company said.
"With the availability of Thelin to physicians and patients in Belgium and Luxembourg, our European commercialisation strategy continues to move forward," said Thierry Plouvier, M.D., vice president, Europe Operations, Encysive (UK) Ltd. "Thelin adds an additional therapeutic option for treating patients with pulmonary arterial hypertension in the EU."
Thelin is an endothelin a receptor antagonist, a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin is 6,500-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor. Highly selective endothelin a receptor antagonism has been shown to increase blood flow and reverse vasoconstriction in human clinical pharmacology studies.
In placebo-controlled clinical trials, the most frequent adverse events that occurred in patients receiving Thelin, were headache, peripheral edema, dizziness, constipation, epistaxis, flushing, international normalized ratio (INR) increase, insomnia, nausea, upper abdominal pain, vomiting, dyspepsia, diarrhoea, fatigue, muscle cramp, and prothrombin time (PT) prolongation and nasal congestion.
It is estimated that PAH afflicts approximately 100,000 to 200,000 people in North America and Europe. The disease is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. As these arteries become increasingly constricted, blood flow and oxygenation may be inadequate to meet the body's demands. Since the heart must then pump harder to overcome the resistance, patients are susceptible to heart failure.
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