Sotatercept, an activin signaling inhibitor, has been recently approved by the FDA for treating pulmonary arterial hypertension (PAH) (see our recent article about the FDA approval at this link), based on two pivotal clinical trials. The authors of the article titled “How We Do It: Using Sotatercept in the Care of Patients with Pulmonary Arterial […]
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
A recent article in “Pulmonary Hypertension News” reports on the tentative approval of Alembic Pharmaceuticals’ generic selexipag as pulmonary arterial hypertension treatment for pulmonary arterial hypertension. Alembic’s generic selexipag contains the same chemical substance as an approved treatment, Uptravi for injection, sold by Johnson & Johnson. Selexipag is a prostacyclin receptor agonist that leads to
Aerovate Therapeutics has announced that its pulmonary arterial hypertension (PAH) candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial. The Phase IIb portion of the IMPAHCT trial aimed to assess three different doses of AV-101, a novel dry powder inhaled formulation of imatinib. The primary endpoint tested
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 Alliance for Pulmonary Hypertension (AfPH) places a strong emphasis on the sharing of knowledge and best practices as a means to empower patients and family members and advance the understanding and treatment of pulmonary hypertension. This is the rationale behind the creation of the Pulmonary Hypertension Knowledge Sharing Platform, an open, inclusive, and dynamic
The history of scientists self-experimenting is filled with fascinating stories. In 1799, a young English chemist, Humphry Davy, later Sir Humphry, discovered “laughing gas” by inhaling nitrous oxide in a sealed box. In the late 1800s, German surgeon August Bier tested spinal anesthesia by injecting himself with cocaine. In the 1940s, American virologist and medical
“Is There a Role for Calcium Channel Blockers in the Contemporary Treatment Paradigm for Pulmonary Arterial Hypertension?” This is the title of an editorial by Lewis Rubin in Circulation, the journal of the American Heart Association, dated May 13, 2024. Among patients with pulmonary arterial hypertension (PAH), acute vasoreactivity testing during right heart catheterization may
Gossamer Bio and Chiesi Group have announced a a global collaboration agreement to develop seralutinib, an inhaled investigational drug for the treatment of pulmonary arterial hypertension. Seralutinib is currently being investigated in the ongoing global Phase 3 trial, PROSERA, for pulmonary arterial hypertension. This collaboration further enhances the resources and expertise devoted to seralutinib and
United Therapeutics has been granted a patent for a method to treat pulmonary arterial hypertension (PAH) by administering endothelial progenitor cells treated with prostacyclin Application n° US17072430, December 12, 2023, Publication Number: US11839631B2. The news was reported in the Magazine “Pharmaceutical Technology, April 4, 2024. To be followed! Read more at this link on the
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
Renamed “Cure HHT” in 2014, the HHT Foundation International was founded by a passionate group of patient families and physicians, who shared a hope for a better future for those with hereditary hemorrhagic telangiectasia (HHT). Since its establishment in 1991, Cure HHT has consistently been at the center of the national (US) and global effort
The 7th edition of the World Symposium on Pulmonary Hypertension is being held on June 29-30/July 1, 2024, in Barcelona, Spain. The WSPH is the most important scientific event in the field of pulmonary hypertension. It has been convened every five years since the Evian edition in 1998 (including Venice 2003, Dana Point 2008, Nice
Corsair Pharma has developed a proprietary transdermal patch intended to provide consistent blood levels of treprostinil, a drug currently administered via a 24/7 infusion pump (sub-cutaneous or intra-venous, see this link for more details), by delivering an inactive prodrug, which crosses the skin, enters the blood, and converts rapidly to treprostinil in the liver. Since
A this PHA live webinar speakers Sandeep Sahay, and Vallerie V. McLaughlin discussed hopeful discoveries from late-stage clinical trials and the differences between current symptom management practices and new disease-modifying therapeutics. The webinar will be moderated by PHA’s Elizabeth Joseloff. This webinar covered the following topics: • The differences between the current symptom management practices
Join the Pulmonary Hypertension Association, PHA, for the upcoming “Discovering New Pulmonary Hypertension Therapies on the Horizon” PHA Live webinar on Wednesday, Feb. 21 at 2 pm. EST/ 7 p.m. UTC. During the webinar, Sandeep Sahay, MD, MSc, ATSF, will review: Don’t miss this opportunity to gain insights into these promising therapies that will help manage your
“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.
