Stage (next event)
Q4 2020 (Est)
Catalyst Info & Data Links
TITLE: Treprostinil Technosphere® for Pulmonary Arterial Hypertension - NDA Submission
ClinicalTrials.gov (NCT03950739): Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso (BREEZE)
WHAT IS THE NEXT CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Q4 2020 (see slide 7)
MECHANISM OF ACTION
Treprostinil Technosphere (TreT) is a combination drug-device product comprised of a dry powder formulation of treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler.
New cases are estimated to occur in one to two individuals per million each year in the U.S. The incidence is estimated to be similar in Europe.
Approximately 500-1000 new cases of PAH are diagnosed each year in the U.S. There is no ethnic or racial group that is known to have a higher frequency of patients with PAH. An exception to this is an apparent paucity of cases of HPAH among subjects of African ancestry, although this may relate to reporting bias and has not been rigorously studied.
Learn more at the National Organization for Rare Disorders (NORD)
Updated by HC
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