Potential PAH Therapy, Trevyent, Being Readied to Request FDA Approval

Malika Ammam, PhD avatar

by Malika Ammam, PhD |

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PAH therapy and FDA

SteadyMed announced that it recently completed the manufacturing of required batches of its drug candidate Trevyent, designed to treat pulmonary arterial hypertension (PAH). The work will allow the company to evaluate the therapy’s shelf-life in advance of submitting a New Drug Application to the U.S. Food and Drug Administration (FDA) early next year.

Trevyent is based on treprostinil, the only parenteral therapy for PAH approved by the FDA for both intravenous and subcutaneous use. In Trevyent, treprostinil is delivered using the company’s PatchPump technology, as a small, single-use PatchPump preprogrammed at a specified delivery rate. The Trevyent PatchPump is equipped with sensors that give the patients audible and visual feedback.

According to the company,existing delivery systems for treprostinil are “multi-component and rather complex.”

“Trevyent, our lead drug product candidate in development for the treatment of Pulmonary Arterial Hypertension (PAH), combines SteadyMed’s proprietary, preservative free formulation of treprostinil and our PatchPump platform technology,” said Jonathan Rigby, president and chief executive officer of SteadyMed, in the press release.

“In our latest manufacturing campaign, we have manufactured thousands of commercial Trevyent units. These units cover the concentration range of currently available Remodulin® (treprostinil, United Therapeutics) and were manufactured … in compliance with current Good Manufacturing Practice (cGMP) standards,” Rigby added. “We … believe we have the necessary capital to launch Trevyent in the U.S. in late 2017, if approved by the FDA.”

PAH is a pulmonary condition where the arteries that transport blood from the heart to the lungs gradually become narrowed. This induces high blood pressure in the lungs due to the restricted blood flow in the vessels. The disease has yet no known cure and the symptoms induced by PAH, including shortness of breath and chest pain, worsen over time.

A number of drugs with variable benefits and side effects are currently available for the treatment of PAH, and they mainly aim to reduce symptoms.

In Other Recent News

According to a new study, oral treprostinil (Orenitram) could benefit patients with pulmonary arterial hypertension (PAH) who are currently dependent on injectable drugs. There is, however, limited data guiding the transition from injection to oral therapies. The case series, which described the transition to oral treprostinil, showed that the switch needs to be performed in a carefully controlled manner to succeed, allowing patients to live a life free from repeated injections.

The study, Oral treprostinil for the treatment of pulmonary arterial hypertension in patients transitioned from parenteral or inhaled prostacyclins: case series and treatment protocol, was published in the journal Pulmonary Circulation.