FDA Pre-market Approval for Remodulin Delivery with Implantable System Pending

Patrícia Silva, PhD avatar

by Patrícia Silva, PhD |

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United Therapeutics Corporation recently announced that Medtronic, Inc., the world’s third largest medical device company, has forwarded a pre-market approval application to the U.S. Food and Drug Administration (FDA) for their proprietary SynchroMed® II implantable drug infusion system, along with a new catheter, to be used with United Therapeutics’s Remodulin® (treprostinil) injectable, formulated for intravenous treatment of pulmonary arterial hypertension (PAH).

Pulmonary arterial hypertension is a result of the abnormal constriction or stenosis of the pulmonary artery, which is responsible for transporting unoxygenated blood from the right side of the heart to the lungs for oxygenation. Without proper and timely management, PAH can gradually progress to heart failure and can greatly reduce quality of life. While Medtronic originally designed the SynchroMed system to deliver Lioresal® Intrathecal (baclofen injection) for ITB Therapy for severe spasticity, PAH patients needing a continuous infusion of Remodulin, a potent vasodilator, may benefit from this drug delivery system.

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United Therapeutics is also working on a New Drug Application for submission to the U.S. FDA in January 2015, for the purpose of amending Remodulin’s label to indicate its compatibility with the SynchroMed II implantable drug infusion system. United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

In other news on treatments for pulmonary arterial hypertension, GlaxoSmithKline (GSK) recently sent an application for a variation to the Marketing Authorization for ambrisentan (Volibris®) to the European Medicines Agency (EMA), aiming for the drug’s use as a first-line combination therapy with tadalafil. Volibris® is classified as a selective endothelin type-A receptor antagonist, and was previously approved in the European Union as a PAH treatment of patients with WHO functional class II and III symptoms, for the purpose of improving physical activity tolerance.

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The EMA application for the extended indication of Volibris comes with supporting evidence from a Phase IIb/IV clinical trial called AMBITION, which was conducted together with Gilead Sciences, Inc. The study evaluated the drug’s efficacy in treating naive adult PAH patients with WHO functional class II and III symptoms in combination with tadalafil.

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