Mini-symposia to focus on long-term extension data for the Tyvaso® INCREASE study, the ralinepag phase 2 study, and the Orenitram® FREEDOM-EV study

Poster presentations touch on real-world treprostinil use, Tyvaso DPI™, and other treprostinil clinical studies

United Therapeutics is hosting a sponsored symposium on PH-ILD and sponsoring the ATS 2022 Women’s Forum

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that eight posters and three mini-symposia across the company’s commercial and development portfolio will be presented at the 2022 American Thoracic Society (ATS) International Conference, taking place May 13-18, 2022, in San Francisco. In addition, the company is hosting a sponsored symposium on pulmonary hypertension associated with interstitial lung disease (PH-ILD) and is sponsoring the ATS 2022 Women’s Forum.

“ATS 2022 will provide us with the opportunity to update the pulmonary hypertension community on long-term data with presentations on the INCREASE, FREEDOM-EV, and phase 2 ralinepag open label extension studies,” said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. “This year’s conference will also allow us to feature poster presentations on Tyvaso DPI, the EXPEDITE study, the ADAPT registry, and real-world outcomes data for our treprostinil products.”

Mini-symposia include:

Mini-symposium, Sunday, May 15, 2:45 - 2:55 PM PT: A96 – Long-Term Data from Study APD811-007, an Open-Label Extension Study Evaluating Ralinepag for the Treatment of Pulmonary Arterial Hypertension. Presented by Elizabeth S. Klings, M.D., Boston University School of Medicine.

Mini-symposium, Sunday, May 15, 3:15 - 3:25 PM PT: A96 – Long-Term Efficacy of Oral Treprostinil in Subjects with Pulmonary Arterial Hypertension: FREEDOM-EV Open-Label Extension Study. Presented by R. James White, M.D., Ph.D., University of Rochester.

Mini-symposium, Monday, May 16, 3:35 - 3:45 PM PT: B96 - Long-Term Effects of Inhaled Treprostinil in Patients with Pulmonary Hypertension Due to Interstitial Lung Disease: The INCREASE Study Open-Label Extension. Presented by Aaron B. Waxman, M.D., Ph.D., Brigham and Women’s Hospital, Boston.

Posters include:

Thematic poster session, Monday, May 16, 11:15 AM - 1:15 PM PT: B53/P202 – Comparison of Pharmacokinetics of 3 Doses of Treprostinil Inhalation Powder (Tyvaso DPI) and 3 Doses of Tyvaso in Healthy Normal Volunteers. Presented by Kareem El-Kersh, M.D., University of Nebraska Medical Center.

Thematic poster session, Monday, May 16, 11:15 AM - 1:15 PM PT: B53/P203 – Rapid Titration of Parenteral Treprostinil to EXPEDITE Dosing of Oral Treprostinil. Presented by Vijay P. Balasubramanian, M.D., MRCP, University of California, San Francisco, Fresno.

Thematic poster session, Monday, May 16, 11:15 AM - 1:15 PM PT: B53/P205 – Strategies to EXPEDITE the Time to Effective Dosing of Oral Treprostinil in Patients with Pulmonary Arterial Hypertension. Presented by Chad E. Miller, M.D., Piedmont Healthcare Atlanta.

Thematic poster session, Monday, May 16, 11:15 AM - 1:15 PM PT: B52/P178 – Incidence and Predictors of Catheter-Related Adverse Events Among Medicare Adult Patients with Pulmonary Arterial Hypertension Using Intravenous Prostacyclin Therapy. Presented by Murali Chakinala, M.D., Washington University St. Louis.

Poster discussion session, Monday, May 16, 2:15 PM - 3:45 PM PT: B106/605 – Clinician-Based Risk Assessment Compared to REVEAL Lite 2 and Parenteral Prostacyclin Utilization in a Physician-Conducted Retrospective Chart Review of Patients with Pulmonary Arterial Hypertension. Presented by Amresh Raina, M.D., Allegheny General Hospital, Pittsburgh.

Poster discussion session, Monday, May 16, 2:15 - 3:45 PM PT: B106/607 – A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in Subjects with Pulmonary Arterial Hypertension (ADVANCE OUTCOMES). Presented by Vallerie Victoria Mclaughlin, M.D., University of Michigan Hospital.

Poster discussion session, Monday, May 16, 2:15 - 3:45 PM PT: B106/608 – Clinical Improvement in Pulmonary Arterial Hypertension (PAH) Patients Transitioning from Selexipag to Oral Treprostinil: Interim Results from the ADAPT Registry. Presented by Daniel J. Lachant, D.O., University of Rochester.

Rapid abstract poster discussion session, Tuesday, May 17, 2:15 PM - 3:45 PM PT: C105/504 – Comparative Effectiveness of Inhaled Treprostinil vs Iloprost in Patients with Pulmonary Arterial Hypertension: An Analysis of U.S. Administrative Claims Data. Presented by Charles D. Burger, M.D., Mayo Clinic Florida.

Sponsored events include:

Sponsored Symposium, Sunday, May 15, 6:30 PM - 9:30 PM PT, A New Frontier in PH-ILD: Screening, Diagnosis, and Treatment Options. Presented by Franck Rahaghi, M.D., MHS, FCCP, Cleveland Clinic Florida; Nicholas Kolaitis, M.D., MAS, University of California, San Francisco; and Steven Nathan, M.D., FCCP, Inova Fairfax Hospital.

The ATS 2022 Women’s Forum,Monday, May 16, 11:45 AM - 1:15 PM PT, featuring Patricia W. Finn, M.D., the Earl M. Bane professor, associate dean for strategic initiative, head of the Department of Medicine, and an associate program director for the Medical Scientist Training Program at the University of Illinois at Chicago.

About TYVASO® (treprostinil) Inhalation Solution

Eyebrow (abbreviated) Indication

• For the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.
• For the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

INDICATION

TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of:

• Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies 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 controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience 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 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 is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.
• TYVASO inhibits platelet aggregation and increases 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.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

• The concomitant use of TYVASO 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 in the placebo-controlled study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs