FDA Approves Riociguat (Adempas) for PAH and CTEPH

News of the approval comes within weeks of an announcement that the drug would be granted 2 separate orphan-drug designations.
medscape.com

Novel PAH Drug Proves Effective in 2 Trials

Two articles in the July 25 edition of the New England Journal of Medicine analyze the efficacy of a novel drug for pulmonary arterial hypertension (PAH).
medscape.com

Riociguat (Adempas) Not for Patients With PH-IIP

An EMA panel has recommended that riociguat not be used in those with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia after review of a safety signal.
medscape.com

FDA Approves Macitentan (Opsumit) for PAH

This is the second agent for pulmonary arterial hypertension this month, following the approval of riociguat October 8.
medscape.com

Macitentan (Opsumit) in PAH Cuts Morbidity/Mortality

Long-term clinical-outcomes data are in short supply for pulmonary artery hypertension drug therapies. Regulators are now looking at macitentan, which is making its case largely on the strength of the three-year, clinical-endpoint-driven SERAPHIN trial.
medscape.com

FDA Clears Selexipag for Pulmonary Arterial Hypertension

The oral IP prostacyclin receptor agonist is indicated to delay disease progression and reduce the risk for hospitalization in adults with PAH.
medscape.com

FDA: Oral Treprostinil for PAH Rejected Again

Treprostinil, already available in injectable drug and inhaled formulations, has seen mixed success in the FREEDOM trial series.
medscape.com

Implant Eliminates External Pump in Pulmonary Hypertension

The programmable device delivers prostanoid treprostinil to patients with severe pulmonary arterial hypertension, freeing them from cumbersome medical equipment.
medscape.com

FDA Clears Two-Drug Combo as First-Line Treatment for PAH

Ambrisentan plus tadalafil in newly diagnosed pulmonary arterial hypertension reduces risk of disease worsening and improves exercise ability.
medscape.com
While it appears that “2 is better than 1” where treatment of a dismal disease like Pulmonary Hypertension goes, not all combinations are equal. Among combinations of phosphodiesterase type 5 inhibitors with endothelin receptor antagonists, Tadanafil + Ambrisentan works, but not Sildenafil + Bosentan.
Currently, there are five drug classes from which physicians can mix-and-match: prostacyclins, guanylate cyclase stimulators, phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, and specific prostacyclin IP receptor agonists. Expect upcoming trials to explore various combinations of these.

Two Drugs Better Than One for Pulmonary Hypertension

New data from the AMBITION trial suggest that combining ambrisentan with tadalafil cuts clinical failure in pulmonary hypertension by 50% compared with either drug alone.
medscape.com

Combination Therapy Improves Pulmonary Hypertension Outcomes

Combination therapy reduces the risk of clinical worsening in idiopathic and connective-tissue-associated pulmonary arterial hypertension better than monotherapy, according to a new meta-analysis.
medscape.com

Bosentan Comes up Empty in Postmarket PAH Trial

Used on top of sildenafil, bosentan failed to demonstrate a reduction in time to first morbidity or mortality compared with placebo treatment in the postmarket COMPASS 2 trial.
medscape.com