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Find Clinical Drug Pipeline Developments & Deals by United Therapeutics
The acquisition of Miromatrix will expand United Therapeutics’ platform of organ manufacturing programs and regenerative medicine and upon the achievement of clinical development milestone to Miromatrix’s development-stage, manufactured kidney product known as mirokidney™.
Tyvaso (treprostinil) inhalation solution is an approved prostacyclin mimetic indicated for the treatment of Pulmonary arterial hypertension. It is under phase 3 clinical development for progressive pulmonary fibrosis.
The acquisition of Miromatrix will expand United Therapeutics’ platform of organ manufacturing programs and regenerative medicine and upon the achievement of clinical development milestone to Miromatrix’s development-stage, manufactured kidney product known as mirokidney™.
Through the acquisition, United Therapeutics gains access to Miromatrix’s development-stage, fully-implantable manufactured kidney product known as mirokidney.
As part of the collaboration, Miromatrix has created a new liver therapy called miroliverELAP that combines a Miromatrix single-use bioengineered liver with Baxter’s PrisMax system for patients with acute liver failure (ALF) in need of organ support therapies.
MiroliverELAP is a single-use bioengineered liver which is designed to provide therapeutic support to ALF patients in hopes their native livers will regenerate themselves back to health.
The miroliverELAP IND application was submitted in mid-November. The FDA indicated they will provide an official clinical hold letter to Miromatrix within 30 days. Miromatrix plans to provide additional updates pending communication with the FDA.
Remodulin (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise.
Data from the FREEDOM-EV open label extension study of Orenitram® details an association with improved survival and, separately, its effects as part of a combination therapy regimen in patients with pulmonary arterial hypertension.
TYVASO (treprostinil) inhalation solution and TYVASO DPI (treprostinil) inhalation powder are prostacyclin mimetics indicated for the treatment of Pulmonary arterial hypertension.
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