Prostacyclin

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Key Points: 


Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution

Retrieved on: 
Tuesday, March 12, 2024

The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Key Points: 
  • The product is being recalled due to the potential for the presence of silicone particulates in the product solution.
  • Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material.
  • Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01.
  • If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

Global Pulmonary Arterial Hypertension (PAH) Industry Research 2023 - ResearchAndMarkets.com

Retrieved on: 
Friday, June 16, 2023

The global pulmonary arterial hypertension market was valued at US$8.18 billion in 2022.

Key Points: 
  • The global pulmonary arterial hypertension market was valued at US$8.18 billion in 2022.
  • Pulmonary arterial hypertension (PAH) is a rare and progressive disorder characterized by elevated blood pressure of more than 25mmHg in the arteries of the lungs, also known as the pulmonary artery.
  • On the other hand, therapeutic options for pulmonary arterial hypertension (PAH) have increased over the last decades.
  • The global pulmonary arterial hypertension market is moderately concentrated.

New Real-World Observational Analysis of UPTRAVI® (selexipag) Underscores the Importance of Risk Assessment for Treating Pulmonary Arterial Hypertension (PAH) Patients

Retrieved on: 
Tuesday, April 6, 2021

In the pivotal GRIPHON trial, UPTRAVI was proven to reduce the risk of disease progression by 40%.

Key Points: 
  • In the pivotal GRIPHON trial, UPTRAVI was proven to reduce the risk of disease progression by 40%.
  • SPHERE enrolled patients who were either newly initiated on UPTRAVI (60 days before enrollment) or previously received UPTRAVI with documentation of dose titration at study enrollment.
  • The efficacy of UPTRAVI in PAH was established in GRIPHON (Prostacyclin [PGI2] Receptor agonist In Pulmonary arterial HypertensiON), the largest randomized, controlled trial ever conducted in PAH patients.
  • Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI and in none of the patients on placebo.

The Global Pulmonary Arterial Hypertension Market is expected to grow from USD 7,196.48 Million in 2019 to USD 9,925.12 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 5.50%

Retrieved on: 
Monday, April 6, 2020

The Prostacyclin & Prostacyclin Analog commanded the largest size in the Pulmonary Arterial Hypertension Market in 2019, followed by the Calcium Channel Blocker.

Key Points: 
  • The Prostacyclin & Prostacyclin Analog commanded the largest size in the Pulmonary Arterial Hypertension Market in 2019, followed by the Calcium Channel Blocker.
  • On the basis of Distribution, the Pulmonary Arterial Hypertension Market is studied across Hospital Pharmacy, Online Pharmacy, and Retail Pharmacy.
  • The Hospital Pharmacy commanded the largest size in the Pulmonary Arterial Hypertension Market in 2019, followed by the Retail Pharmacy.
  • On the basis of Geography, the Pulmonary Arterial Hypertension Market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa.

Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal

Retrieved on: 
Friday, April 3, 2020

The consensus opinions were formed utilizing the RAND/University of California Los Angeles Appropriateness Method, which incorporates the Delphi method and nominal group technique.

Key Points: 
  • The consensus opinions were formed utilizing the RAND/University of California Los Angeles Appropriateness Method, which incorporates the Delphi method and nominal group technique.
  • The Prostacyclin International Expert Panel opinion survey statements are not intended to be formal treatment guidelines or recommendations, and survey results presented here must be validated with rigorous prospective studies.
  • The Prostacyclin International Expert Panel opinion survey statements cannot replace assessment and/or clinical decision-making by a qualified healthcare practitioner for an individual patient.
  • UPTRAVI is the only oral treatment that works on the prostacyclin pathway with evidence of long-term outcomes.

Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis Report By Drug Class And Segment Forecasts, 2020 - 2027

Retrieved on: 
Thursday, March 5, 2020

Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis Report By Drug Class (Prostacyclin & Prostacyclin Analogs, Endothelin Receptor Antagonists, Phosphodiesterase 5), And Segment Forecasts, 2020 - 2027

Key Points: 
  • Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis Report By Drug Class (Prostacyclin & Prostacyclin Analogs, Endothelin Receptor Antagonists, Phosphodiesterase 5), And Segment Forecasts, 2020 - 2027
    The global pulmonary arterial hypertension market size is expected to reach USD 9.8 billion by 2027., registering a CAGR of 5.6% over the forecast period.
  • Increasing prevalence rates of pulmonary arterial hypertension (PAH) and government support for the development of orphan drugs drive the market growth.
  • In September 2019, Acceleron Pharma, a leading biopharmaceutical company, received FDA orphan drug designation for sotatercept for the treatment of pulmonary arterial hypertension.
  • Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

Orenitram (treprostinil; United Therapeutics) Market Overview - Newer Brand Uptravi (selexipag; Johnson & Johnson/Nippon Shinyaku) Poses Tough Competition in the Oral Prostacyclin Class

Retrieved on: 
Wednesday, June 26, 2019

Orenitram (treprostinil; United Therapeutics) is a novel formulation of the prostacyclin analog treprostinil, formulated using Supernus Pharmaceuticals' drug delivery technology, allowing for twice-daily oral dosing.

Key Points: 
  • Orenitram (treprostinil; United Therapeutics) is a novel formulation of the prostacyclin analog treprostinil, formulated using Supernus Pharmaceuticals' drug delivery technology, allowing for twice-daily oral dosing.
  • Moreover, newer brand Uptravi (selexipag; Johnson & Johnson/Nippon Shinyaku) poses tough competition in the oral prostacyclin class.
  • While United Therapeutics is investing in further developing Orenitram, the author ultimately does not foresee Orenitram outcompeting Uptravi as the former's clinical profile is unconvincing.
  • Nevertheless, Orenitram is still expected to indirectly benefit from the TRITON trial investigating the value of triple combination therapy with an oral prostacyclin.

Remodulin (treprostinil; United Therapeutics/Mochida) Overview: United Therapeutics is Developing Three New Formulations of Remodulin to Overcome Administration Difficulties

Retrieved on: 
Wednesday, June 26, 2019

Remodulin (United Therapeutics/Mochida) contains treprostinil, which is a prostaglandin analog that functions as a prostaglandin I2 receptor agonist.

Key Points: 
  • Remodulin (United Therapeutics/Mochida) contains treprostinil, which is a prostaglandin analog that functions as a prostaglandin I2 receptor agonist.
  • This leads to potent vasodilation of the pulmonary arteries and inhibition of platelet aggregation.
  • Remodulin (treprostinil; United Therapeutics/Mochida) is a last-line treatment option for more severe patients.
  • Accordingly, United Therapeutics is developing three new formulations of Remodulin to overcome administration difficulties.

Orenitram (treprostinil; United Therapeutics) Drug Profile 2016-2025 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 26, 2019

Orenitram (treprostinil; United Therapeutics) is a novel formulation of the prostacyclin analog treprostinil, formulated using Supernus Pharmaceuticals' drug delivery technology, allowing for twice-daily oral dosing.

Key Points: 
  • Orenitram (treprostinil; United Therapeutics) is a novel formulation of the prostacyclin analog treprostinil, formulated using Supernus Pharmaceuticals' drug delivery technology, allowing for twice-daily oral dosing.
  • Orenitram represents the continuation of United Therapeutics' PH portfolio, led by intravenous Remodulin.
  • While United Therapeutics is investing in further developing Orenitram, the author ultimately does not foresee Orenitram outcompeting Uptravi as the former's clinical profile is unconvincing.
  • Nevertheless, Orenitram is still expected to indirectly benefit from the TRITON trial investigating the value of triple combination therapy with an oral prostacyclin