Data from the BREEZE open-label extension study of Tyvaso DPI® detail its long-term outcomes and dosing in patients with pulmonary arterial hypertension

United Therapeutics is sponsoring the Tyvaso DPI®: Clinical Pearls and Drug-Device Characteristics Symposium

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that five presentations and one poster across its commercial and development portfolio will be presented at the CHEST 2024 Annual Meeting hosted by the American College of Chest Physicians taking place October 6-9, 2024, in Boston. United Therapeutics will sponsor the Tyvaso DPI®: Clinical Pearls and Drug-Device Characteristics Symposium.In addition, United Therapeutics is proud to sponsor the Women in Chest Medicine Annual Luncheon and the Advanced Practice Providers (APPs) in Chest Medicine Forum.

“The CHEST Annual Meeting remains an important event for United Therapeutics and the pulmonary hypertension community, and this year we are excited to share additional analyses, particularly from the BREEZE open-label extension study, that continue to expand on these important learnings,” said Andrew Nelsen, PharmD,Vice President, Global Medical Affairs at United Therapeutics. “Equally, we are proud to sponsor a symposium entitled Tyvaso DPI®: Clinical Pearls and Drug-Device Characteristics, as well as a series of rapid-fire presentations showing interesting findings in health care resource utilization, patient reported outcomes, and health-related qualify of life.”

Oral Presentations include:

Rapid fire original investigation presentation, Tuesday, October 8, 10:20 a.m. to 10:24 a.m. ET: Rapid Area 4B/4071 – Patient-Reported Symptom Burden and Health-Related Quality of Life in Pulmonary Arterial Hypertension: Results from a Patient’s Perspective on Palliative Care Online Survey. Presented by Denise Sese, M.D., Medical University of South Carolina.

Rapid fire original investigation presentation, Tuesday, October 8, 10:32 a.m. to 10:36 a.m. ET: Rapid Area 4B/4071 – Initial Validation of the Pulmonary Hypertension Functional Classification Self-Report (PH-FC-SR): A Patient Focused Measure for Use in Research and in the Clinic.Presented by Kristin Highland, M.D., FCCP, Cleveland Clinic.

Rapid fire original investigation presentation, Tuesday, October 8, 1:45 p.m. to 1:49 p.m. ET: Rapid Area 4A/4072 – Real-World Hospitalization Differences in Patients with Pulmonary Hypertension due to Interstitial Lung Disease: Initiating Inhaled Treprostinil vs. Those Who Remain Untreated. Presented by Steven Cassady, M.D., University of Maryland Medical Center.

Rapid fire original investigation presentation, Tuesday, October 8, 2:03 p.m. to 2:07 p.m. ET: Rapid Area 4A/4072 – Long-Term Outcomes and Dosing in the BREEZE Study Optional Extension Phase. Presented by Abubakr Bajwa, MBBS, FCCP, Mayo Clinic.

Rapid fire original investigation presentation, Tuesday, October 8, 2:21 p.m. to 2:25 p.m. ET: Rapid Area 4A/4072 – Inhaled Treprostinil for the Treatment of Connective Tissue-Associated Pulmonary Arterial Hypertension.Presented by Kristin Highland, M.D., FCCP, Cleveland Clinic.

Posters include:

Poster discussion session, Wednesday, October 9, 10:20 a.m. to 11:05 a.m. ET: 4529/4430 – Real-World Oral Treprostinil Initiations: Insights from Specialty Pharmacy Data.Presented by Daniel Lachant, D.O., University of Rochester Medical Center.

Sponsored events include:

The APPs in Chest Medicine Forum, Sunday, October 6, 12:00 to 1:30 p.m. ET. The event will include a brief presentation on navigating opportunities and challenges APPs face in clinical practice, led by Danielle McCamey, DNP, CRNP, ACNP-BC, FCCP; and Corinne Young, MSN, FNP-C, FCCP. Presenters will give practical tips for making the most of the CHEST 2024 experience. The forum will be held in the Contemporary Ballroom at the Omni Hotel.

The Women in Chest Medicine Annual Luncheon,Monday, October 7, 12:00 to 1:30 p.m. ET. National negotiation expert and best-selling author, Sara Laschever, will facilitate an interactive conversation about cultivating effective negotiation skills and how to be your best self-advocate. In addition, the 2024 recipient of the CHEST Women’s Lung Health grant will be honored at the luncheon. The luncheon will be held in room 156A at the Boston Convention and Exhibition Center.

Tyvaso DPI® (Treprostinil Inhalation Powder): Clinical Pearls and Drug-Device Characteristics, Monday, October 7, 6:00 to 9:00 p.m. ET, featuring Anthony Hickey, Ph.D., Sc.D., University of North Carolina at Chapel Hill; Jennifer H Keeley, DNP, Allegheny General Hospital; and Sandeep Sahay, M.D., FCCP, Houston Methodist Hospital. The symposium will be held at the Omni Boston Hotel at the Seaport, Momentum ABC Ballroom, Level 5.

About Tyvaso® Inhalation Solution and Tyvaso DPI® Inhalation Powder

INDICATION

TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics indicated for the treatment of:

Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with TYVASO establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with TYVASO was limited to 12 weeks in duration.

Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with TYVASO establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension.

Both products inhibit platelet aggregation and increase the risk of bleeding.

Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.

Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO and TYVASO DPI.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

The concomitant use of either product with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.

Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.

Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.

Safety and effectiveness in pediatric patients have not been established.

Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH‑ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

ADVERSE REACTIONS

Pulmonary Arterial Hypertension (WHO Group 1)

In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs

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