Research-based pharmaceutical and healthcare company GSK has completed regulatory submission to the European Medicines Agency (EMA) regarding a series of Marketing Authorizations for ambrisentan (Volibris), their therapy for pulmonary arterial hypertension (PAH). The company has filed the submission based on encouraging results recently made public from the phase IIIb/IV AMBITION study.
Ambrisentan is a selective endothelin type-A receptor antagonist that has already been approved in the European Union (EU) as a therapeutic option for adults who suffer from functional class II and III PAH, according to the World Health Organization classification. The treatment has been proven effective in improving PAH patients’ exercise abilities.
In addition, company conducted the phase IIIb/IV AMBITION study in partnership with Gilead Sciences Inc. to assess the initial combination therapy of ambrisentan and tadalafil in treatment naïve PAH patients with WHO functional class II and III symptoms.
“We hope that evidence from the AMBITION study, which showed that starting initial combination of ambrisentan and tadalafil was superior to first-line monotherapy with either medicine alone, will help support the management of patients who suffer with this rare and debilitating lung disease,” explained the Senior Vice President, Head of GSK Rare Diseases Research & Development, Carlo Russo.
“This submission has been part of our efforts to continue to help patients with pulmonary arterial hypertension and we look forward to the outcome,” Russo added, as the company is also planning on filing additional regulatory submissions in other countries by the end of 2014 and throughout 2015.
Ambrisentan is commercialized in the Unites States by Gilead under the trade name Letairis, and by GSK in other countries with the trade name Volibris. The product has been granted orphan drug designation in Europe, the United States, Japan and Korea as a treatment for PAH.
The two companies continue to focus on offering an alternative therapy for the treatment of the condition that affects about 200,000 people all over the world, causing constriction of the blood vessels in the lungs, and consequently high pulmonary arterial pressure. The high pulmonary arterial pressures increase the difficulties for the heart to properly pump blood to the lungs and oxygenate them. Therefore, a common symptom associated with the disease is shortness of breath due to the struggle of the heart to pump against the high pressures, making it a deadly disease as many patients eventually suffer heart failure.