Since sotatercept received Food and Drug Administration (FDA) approval for pulmonary arterial hypertension in March 2024, knowing when and how to use it has become an essential part of managing this serious condition — so say the authors of a recently published article in CHEST, who offer a practical guide for clinicians navigating this new […]
This review covers the full clinical picture of pulmonary arterial hypertension (PAH) — from its pathophysiology and diagnosis through to current and emerging treatments. Understanding the Disease Pulmonary arterial hypertension is driven by progressive structural remodelling of the pulmonary arteries, creating a vicious cycle of vasoconstriction, inflammation, and uncontrolled cell growth that ultimately leads to
A Japanese study has confirmed that sotatercept works just as well in Asian patients, even though pulmonary arterial hypertension presents somewhat differently in the Asian population: patients tend to have longer disease duration, more severe baseline profiles, and are more frequently on intensive triple therapy including parenteral prostacyclin. This was a regional Phase 3, open-label
United Therapeutics has announced promising results from its pivotal Phase 3 ADVANCE OUTCOMES study of ralinepag, a new oral treatment for pulmonary arterial hypertension (PAH). Ralinepag is a highly selective prostacyclin (IP) receptor agonist that works through multiple pathways — vasodilatory, anti-proliferative, and anti-inflammatory. It is taken once daily orally, yet achieves sustained receptor activity
Nippon Shinyaku recently reported progress on two Phase 2 trials of its oral candidate NS-863, targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), both serious cardiopulmonary conditions with high unmet need. By advancing NS-863 across two related indications, the company is signaling a deeper push into rare cardiopulmonary therapeutics,
Pulmonary arterial hypertension (PAH) is a progressive, life-threatening disease where early detection is strongly encouraged to prevent irreversible vascular and cardiac damage. However, a fundamental paradox exists: while clinicians are urged to diagnose pulmonary arterial hypertension early, treatment is restricted to symptomatic patients (New York Heart Association (NYHA) functional class II or higher), leaving asymptomatic
The Alliance for Pulmonary Hypertension (AfPH) recently concluded its 14th webinar, marking the culmination of an educational initiative that began in June 2023. These virtual gatherings brought together internationally renowned experts in pulmonary hypertension, who shared their expertise on a comprehensive range of topics crucial to advancing patient care and quality of life. The diverse
The first-in-class pulmonary arterial hypertension drug sotatercept was approved in March 2024 by the Food and Drug Administration (FDA) in the USA and the approval of the European Medicines Agency (EMA) is expected in the next few months. The UK Pulmonary Hypertension Association, PHA UK, has put together a short video, with its Chair Dr
On 28 June 2024 the European Medicines Agency has issued a press release to say that the CHMP (human medicines committee) has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity. This is the first step
The full transcripts of the Alliance for Pulmonary Hypertension’s 2023 six webinars are now available! The transcripts encapsulate invaluable insights that continue to resonate with current trends and emerging issues, serving as a vital resource for our community. They are now in a format that can be translated into 40 languages, thanks to the embedded
The US Food and Drug Administration has approved sotatercept, Merck‘s new drug for pulmonary arterial hypertension. It’s commercial name is Winrevair. Read more on the FDA website at this link Sotatercept is an activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein. It was evaluated as an add-on to stable background therapy for the treatment of pulmonary
On March 22, 2024 the Food and Drug Administration (FDA), the US drug regulatory authority, approved the single-tablet macitentan/tadalafil combination (Opsynvi) for pulmonary arterial hypertension. The application to the FDA was submitted by the Janssen Pharmaceutical Companies of Johnson & Johnson on May 30, 2023. The FDA approval is based on the results of the
The PROSERA Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of the oral Inhalation of seralutinib for the treatment of pulmonary arterial hypertension is currently enrolling. The PROSERA study’s objective is to understand the effect of seralutinib on specific pathways in the body that lead to the inflammation, proliferation and fibrosis
“EXPOSURE” (EUPAS19085) is an observational study describing the characteristics, treatment patterns, and outcomes of patients with pulmonary arterial hypertension initiating a new specific therapy in Europe/Canada. In total, 1.944 patients with follow-up information were included. Most study patients were female with WHO functional class II/III symptoms and idiopathic or connective tissue disorder-associated pulmonary arterial hypertension.
Prof. Adam Torbicki’s presentation is titled “Access to care for pulmonary arterial hypertension and chronic thromboembolic pulmponary hypertension”. It can be viewed at this link on Vimeo (you need to register on Vimeo to see it) Prof. Jean-Luc Vachiéry’s presentation is titled “Drug development and clinical trials“. It can be viewed at this link on
The Alliance for Pulmonary Hypertension has just held the last webinar of the six-part series it launched in June 2023 exploring the innovations outlined in the 2022 joint clinical guidelines on pulmonary hypertension by the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Across these six insightful sessions, we delved into pivotal
This survey, the first of its kind, has been designed to help improve global understandings of how pulmonary hypertension affects the lives of patients and in what ways pulmonary hypertension care needs to be improved. The survey has been written by a multidisciplinary panel of pulmonary hypertension specialists and patient group advocates from the pulmonary
Did you know that the lay summary of the European Society of Cardiology and European Respiratory Society clinical guidelines on pulmonary hypertension is now available in 11 languages: English, French, German, Greek, Italian, Polish, Portuguese (Portugal), Russian, Spanish, Romanian, Ukrainian. The English version of the lay summary was developed with the active collaboration of the two
Keros Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application to conduct a Phase 2 clinical trial of KER-012, TROPOS, in combination with background therapy in patients with pulmonary arterial hypertension. KER-012 KER-012 is designed to normalize blood vessel thickness and heart function in pulmonary hypertension.
📣 Yesterday, August 14 2023, the The Lancet published a ground-breaking three-paper series on pulmonary hypertension. 1️⃣ In the first paper, Prof. Marc Humbert and colleagues provide an overview of the pathophysiology of pulmonary arterial hypertension, current therapeutic approaches, and emerging treatment options, with a forward-looking discussion of innovative solutions for future clinical trials. We
