GSK and Gilead’s combination therapy: positive results in PAH

GlaxoSmithKline (GSK) and Gilead Sciences have presented statistically significant results from their phase III AMBITION trial into Letairis (ambrisentan) and tadalafil (Adcirca) for pulmonary arterial hypertension (PAH).

The combination therapy was reported to reduce the risk of clinical failure by 50 per cent in patients with PAH during the European Respiratory Society (ERS) international congress in Germany this week.

“The length of time before patients experienced clinical failure was significantly prolonged for those receiving first-line combination compared to monotherapy,” GSK said.

“The pulmonary hypertension medical community has long been interested in determining whether newly diagnosed PAH patients would have improved outcomes with upfront combination therapy versus monotherapy,” said Dr Lewis J Rubin, emeritus professor, University of California, San Diego and co-chair of the AMBITION steering committee. “The majority of combination studies to date have evaluated add-on combination treatment approaches with mixed results. Thus, having demonstrated a 50 per cent reduction in risk of clinical failure, the AMBITION results using ambrisentan and tadalafil together as upfront combination therapy potentially establish a new treatment paradigm in PAH.”

The treatment effect observed with the primary endpoint was mainly driven by a reduction in hospitalisations, with time to first hospitalisation reduced by 63 per cent.

The positive results will help bolster GSK’s respiratory portfolio, which has been weaker in recent months.

PAH is characterised by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures. PAH sufferers have shortness of breath as the heart struggles to pump, causing ultimate death from heart failure. It affects approximately 200,000 patients worldwide.

The two companies will now apply for regulatory approval in the US, European Union and beyond, using data from the AMBITION study.

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