United Therapeutics to Feature Clinical Data Across its Commercial and Development Portfolio at the CHEST 2024 Annual Meeting
United Therapeutics (Nasdaq: UTHR) announced its participation in the CHEST 2024 Annual Meeting from October 6-9, 2024, in Boston. The company will present five oral presentations and one poster across its commercial and development portfolio. Key highlights include:
1. Data from the BREEZE open-label extension study of Tyvaso DPI®, detailing long-term outcomes and dosing in pulmonary arterial hypertension patients.
2. A sponsored symposium on Tyvaso DPI®: Clinical Pearls and Drug-Device Characteristics.
3. Presentations on patient-reported outcomes, health-related quality of life, and real-world hospitalization differences in pulmonary hypertension patients.
4. Sponsorship of the Women in Chest Medicine Annual Luncheon and the Advanced Practice Providers in Chest Medicine Forum.
United Therapeutics (Nasdaq: UTHR) ha annunciato la sua partecipazione al CHEST 2024 Annual Meeting dal 6 al 9 ottobre 2024 a Boston. L'azienda presenterà cinque presentazioni orali e un poster sul suo portfolio commerciale e di sviluppo. I punti salienti includono:
1. Dati dallo studio di estensione open-label BREEZE di Tyvaso DPI®, che dettagli nei risultati a lungo termine e nel dosaggio nei pazienti affetti da ipertensione arteriosa polmonare.
2. Un simposio sponsorizzato su Tyvaso DPI®: Clinica e Caratteristiche del Farmaco e Dispositivo.
3. Presentazioni su esiti riferiti dai pazienti, qualità della vita correlata alla salute e differenze nelle ospedalizzazioni nel mondo reale nei pazienti con ipertensione polmonare.
4. Sponsorizzazione del Pranzo Annuale delle Donne in Medicina Toracica e del Forum dei Fornitori di Pratiche Avanzate in Medicina Toracica.
United Therapeutics (Nasdaq: UTHR) anunció su participación en el CHEST 2024 Annual Meeting del 6 al 9 de octubre de 2024 en Boston. La compañía presentará cinco presentaciones orales y un póster en su portafolio comercial y de desarrollo. Los puntos destacados incluyen:
1. Datos del estudio de extensión abierto BREEZE de Tyvaso DPI®, que detalla los resultados a largo plazo y la dosificación en pacientes con hipertensión arterial pulmonar.
2. Un simposio patrocinado sobre Tyvaso DPI®: Perlas Clínicas y Características del Medicamento y Dispositivo.
3. Presentaciones sobre resultados informados por los pacientes, calidad de vida relacionada con la salud y diferencias en hospitalizaciones en el mundo real en pacientes con hipertensión pulmonar.
4. Patrocinio del Almuerzo Anual de Mujeres en Medicina Torácica y del Foro de Proveedores de Práctica Avanzada en Medicina Torácica.
유나이티드 테라퓨틱스(Nasdaq: UTHR)는 2024년 10월 6일부터 9일까지 보스턴에서 열리는 CHEST 2024 Annual Meeting에 참여한다고 발표했습니다. 회사는 상업 및 개발 포트폴리오에서 다섯 개의 구두 발표와 하나의 포스터를 발표할 예정입니다. 주요 내용은 다음과 같습니다:
1. 폐동맥 고혈압 환자의 장기 결과 및 투여량을 자세히 설명하는 BREEZE 공개 라벨 연장 연구에서의 데이터.
2. Tyvaso DPI®: 임상 정보 및 약물-기기 특성에 대한 후원 심포지엄.
3. 폐고혈압 환자의 환자 보고 결과, 건강 관련 삶의 질 및 실제 병원에 입원하는 차이에 대한 발표.
4. 흉부 의학 분야 여성 연례 점심 및 흉부 의학 포럼의 후원.
United Therapeutics (Nasdaq: UTHR) a annoncé sa participation au CHEST 2024 Annual Meeting qui se déroulera du 6 au 9 octobre 2024 à Boston. L'entreprise présentera cinq présentations orales et un poster de son portefeuille commercial et de développement. Les points clés incluent :
1. Des données de l'étude d'extension ouverte BREEZE de Tyvaso DPI®, détaillant les résultats à long terme et le dosage chez les patients atteints d'hypertension artérielle pulmonaire.
2. Un symposium parrainé sur Tyvaso DPI® : Observations Cliniques et Caractéristiques des Médicaments et Dispositifs.
3. Des présentations sur les résultats rapportés par les patients, la qualité de vie liée à la santé et les différences d'hospitalisation dans le monde réel chez les patients atteints d'hypertension pulmonaire.
4. Parrainage du déjeuner annuel des femmes en médecine thoracique et du forum des prestataires de soins avancés en médecine thoracique.
United Therapeutics (Nasdaq: UTHR) hat seine Teilnahme am CHEST 2024 Annual Meeting vom 6. bis 9. Oktober 2024 in Boston angekündigt. Das Unternehmen wird fünf mündliche Präsentationen und ein Poster aus seinem kommerziellen und Entwicklungsportfolio vorstellen. Zu den wichtigsten Punkten gehören:
1. Daten aus der BREEZE-Open-Label-Verlängerungsstudie zu Tyvaso DPI®, die langfristige Ergebnisse und Dosierung bei Patienten mit pulmonaler arterieller Hypertonie beschreibt.
2. Ein gesponsertes Symposium über Tyvaso DPI®: Klinische Kenntnisse und Arzneimittel-Geräteeigenschaften.
3. Präsentationen über patientenberichtete Ergebnisse, gesundheitsbezogene Lebensqualität und Unterschiede bei Hospitalisierungen in der realen Welt bei Patienten mit pulmonaler Hypertonie.
4. Sponsoring des Frauen in der Thoraxmedizin Jahrestreffens und des Forums für Praktizierende in der Thoraxmedizin.
- Presentation of long-term outcomes and dosing data from the BREEZE open-label extension study of Tyvaso DPI®
- Sponsorship of key events at CHEST 2024, including a symposium on Tyvaso DPI®
- Multiple presentations on patient-reported outcomes and real-world data in pulmonary hypertension
- None.
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
“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
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
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 (
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) (
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 (
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 ≥
In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of TYVASO who switched to a corresponding dose of TYVASO DPI, the most commonly reported adverse events seen with TYVASO DPI in ≥
Pulmonary Hypertension Associated with ILD (WHO Group 3)
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions with TYVASO were similar to the experience in studies of PAH.
Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.TYVASOHCP.com or call 1‑877‑UNITHER (1-877-864-8437).
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United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
You can learn more about what it means to be a PBC here: unither.com/pbc.
Forward-Looking Statements
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of September 24, 2024, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.
TYVASO and TYVASO DPI are registered trademarks of United Therapeutics Corporation.
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