United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that four posters and one oral presentation will be presented at the European Society of Cardiology (ESC) Congress 2022, taking place August 26-29, 2022, and the European Respiratory Society (ERS) International Congress 2022, taking place September 4-6, 2022. Both congresses will be held in Barcelona, Spain.
The presentation and posters describe completed and ongoing clinical studies of Tyvaso® (treprostinil) Inhalation Solution and Orenitram® (treprostinil) Extended-Release Tablets.
“Along with the presentation of data on event-free survival in the open-label portion of the INCREASE clinical study of Tyvaso in pulmonary hypertension associated with interstitial lung disease, ERS 2022 provides us the opportunity to present additional details of the ongoing TETON studies of Tyvaso in idiopathic pulmonary fibrosis,” said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. “Additionally, at both ERS and ESC we’re delighted to present new clinical data describing the use of Orenitram in patients on dual background therapy for pulmonary arterial hypertension.”
ESC posters include:
Moderated e-poster session,Sunday, August 28, 11:15 AM - 12:00 PM CET: Station 7 – Efficacy and dose-response relationship of oral treprostinil in PAH patients on monotherapy or dual background therapy. Presented by Joan Albert Barberà, M.D., Ph.D., Hospital Clínic de Barcelona.
Moderated e-poster session, Sunday, August 28, 11:15 AM -12:00 PM CET: Station 7 – Change in REVEAL Lite 2 and COMPERA 2.0 risk status in patients with pulmonary arterial hypertension initiating oral treprostinil on dual background therapy: a retrospective chart review. Presented by Margaret Sketch, Pharm.D., M.P.H, United Therapeutics Corporation.
ERS INCREASE oral presentation details:
Oral presentation, Monday, September 5, 11:55 AM - 12:00 PM CET: 8L/OA2279 – Inhaled treprostinil in patients with pulmonary hypertension due to interstitial lung disease: event-free survival in INCREASE study open-label extension. Presented by Steven D. Nathan, M.D., FCCP, Inova Fairfax Hospital.
ERS posters include:
Thematic poster session, Monday, September 5, 8:30 AM - 9:30 AM CET: TP-23/PA1934 – Study design and rationale for the TETON phase 3 clinical trials of inhaled treprostinil in the treatment of idiopathic pulmonary fibrosis. Presented by Steven D. Nathan, M.D., FCCP, Inova Fairfax Hospital.
Thematic poster session, Monday, September 5, 1:00 PM - 2:00 PM CET: TP-24/PA2682 – Efficacy of oral treprostinil as an add-on therapy for PAH. Presented by David Kiely, BSc (Hons), M.D., FRCP, University of Sheffield.
About Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI™ (treprostinil) Inhalation Powder
TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat:
- Pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. TYVASO or TYVASO DPI can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO or TYVASO DPI. It is not known if TYVASO or TYVASO DPI is safe and effective in children under 18 years of age.
- Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), which is high blood pressure in the lungs due to inflammation and sometimes scarring in the lungs. TYVASO or TYVASO DPI can improve the ability to exercise.
IMPORTANT SAFETY INFORMATION
Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all of your medical conditions, including if you:
- Have low blood pressure
- Have or have had bleeding problems
- Have asthma or chronic obstructive pulmonary disease (COPD)
- Are pregnant or plan to become pregnant. It is not known if either product will harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if either product passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Either product and other medicines may affect each other.
Especially tell your healthcare provider if you take:
- Medicines used to treat high blood pressure or heart disease
- Medicines that decrease blood clotting (anticoagulants)
- Water pills (diuretics)
- Gemfibrozil (Lopid®) or rifampin (Rimactane®, Rifadin®, Rifamate®, Rifater®)
What are the possible side effects of TYVASO or TYVASO DPI?
Both products can cause serious side effects, including:
- Low blood pressure (symptomatic hypotension). If you have low blood pressure, either product may lower your blood pressure more.
- Bleeding problems. Either product may increase the risk of bleeding, especially in people who take blood thinners (anticoagulants).
The most common side effects of both products are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, diarrhea, and shortness of breath. Like other inhaled prostaglandins, you may have trouble breathing after taking TYVASO or TYVASO DPI because it may cause the muscles around your airway to tighten (bronchospasm). These are not all the possible side effects. Call your doctor for medical advice about side effects or if you have trouble breathing.
You may report side effects to the FDA at www.fda.gov/MedWatchor call 1-800-FDA-1088.
The risk information provided here is not comprehensive. To learn more about TYVASO or TYVASO DPI, talk with your healthcare provider. 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.TYVASO.com or call 1-877-UNITHER (1‑877‑864‑8437).
About Orenitram® (treprostinil) Extended-Release Tablets
Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Orenitram can help slow down the progression of your disease and improve your ability to exercise. It is not known if Orenitram is safe and effective in children.
Important Safety Information for Orenitram
Who should not take Orenitram?
Do not take Orenitram if you have severe liver problems.
What should I tell my healthcare provider before taking Orenitram?
Tell your healthcare provider:
- If you have liver problems or diverticulosis.
- If you are pregnant, breastfeeding, and/or plan to become pregnant or breastfeed. It is not known if Orenitram will harm your unborn baby or if Orenitram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Orenitram.
- About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your healthcare provider. Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin® or Tyvaso®.
How should I take Orenitram?
- Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.
- Orenitram is usually taken 3 times a day (about every 8 hours) or 2 times a day (about every 12 hours). Your healthcare provider will tell you how often you should take Orenitram. If you have side effects, your healthcare provider may tell you to change your dose or when you take Orenitram. Take Orenitram with food.
- Swallow Orenitram tablets whole. Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. If Orenitram tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects.
- If you miss your dose of Orenitram, take the missed dose as soon as possible with food.
- If you miss 2 or more doses of Orenitram, call your healthcare provider to see if you need to change your dose.
- If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.
- You may see the tablet shell in your stools (bowel movements). This is usually normal. The tablet shell is not digested. If you have diverticulosis, the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.
What are the possible side effects of Orenitram?
Orenitram can cause serious side effects, including worsening of PAH symptoms.
- Stopping Orenitram suddenly may cause worsening of your PAH symptoms. Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.
- The most common side effects of Orenitram include headache, diarrhea, nausea, vomiting, flushing, and pain in arms, legs, and jaw. These are not all of the possible side effects of Orenitram. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
- Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.
The risk information provided here is not comprehensive. To learn more about Orenitram, talk with your healthcare provider. Please see Full Prescribing Information and Patient Information at www.orenitram.com or call Customer Service at 1-877-UNITHER (1‑877-864-8437).
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. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
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, statements relating to upcoming medical conference posters and presentations, 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, providing superior financial performance for shareholders, and providing our communities with earth-sensitive energy utilization. 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 August 24, 2022 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 ORENITRAM are registered trademarks of United Therapeutics Corporation.
TYVASO DPI is a trademark of United Therapeutics Corporation.
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