GSK, Gilead's pulmonary hypertension combo smashes goals in phase III trial
- GlaxoSmithKline and Gilead Sciences presented data at the European Respiratory Society International Congress in Munich, Germany on Monday showing that combination first-line treatment of patients with pulmonary arterial hypertension (PAH) with ambrisentan and tadalafil produced significantly better results than monotherapy with either drug.
- In a phase IIIb/IV trial, the combination therapy reduced the risk of clinical failure -- defined as the time to death, hospitalization, disease progression, or unsatisfactory long-term clinical response -- by a staggering 50% compared to pooled monotherapy.
- The companies are expected to use the data to submit approval for a combination first-line treatment using the drugs. A combo therapy of the two is not currently approved anywhere in the world.
Preclinical studies had suggested that these two drugs could complement each other -- now, GSK and Gilead have the data to prove it. Although ambrisentan and tadalafil are both approved in the EU, the U.S., and many other countries, a combination therapy of the two is not certified anywhere in the world. Gilead spokespeople said that the company would be using the data from the AMBITION trial to submit a supplemental new drug application (sNDA) to the FDA "by the end of this year."
The top-line data about the dual-treatment's ability to significantly prolong the number of days patients go without experiencing clinical failure is sure to garner most of the attention; but the trial also showed the therapy met secondary endpoints such as improving patients' scores on a six-minute walk test.
- Business Wire First-Line Combination of Ambrisentan and Tadalafil Reduces Risk of Clinical Failure Compared to Monotherapy in Pulmonary Arterial Hypertension Outcomes Study
- PharmaBiz GSK announces phase IIIb/IV study of combo therapy of ambrisentan/tadalafil to treat naïve patients with PAH meets primary endpoint