US FDA approves a high-strength formulation of Actelion's Ventavis
This article was originally published in Scrip
The US FDA has approved a new 20mg/ml formulation of Actelion's inhaled prostacyclin analogue, Ventavis (Iloprost), for the treatment of pulmonary arterial hypertension.
The company says the increased strength version will deliver the same dose in half of the volume, which is expected to reduce inhalation time, thus supporting patient compliance. Ventavis is a synthetic analogue of the prostacyclin (PG12) hormone. It acts to produce potent pulmonary vasodilation, inhibit platelet aggregation, and bind to receptors on smooth muscle cells, improving their function.
The original formulation of Ventavis has a concentration of 10mg/ml and is administered six to nine times per day. Until earlier this month, this 10mg/ml formulation was the only inhaled prostacyclin product on the market for the treatment of PAH.
The ease of administration of Ventavis became an important factor when United Therapeutics' inhaled formulation of treprostinil, Tyvaso, was recently approved for PAH. Since it is dosed four times per day, its administration has been deemed more convenient to use than Ventavis (scripnews.com, August 3rd, 2009).
Roger Jeffs, United Therapeutics' president, has previously said that he expects Tyvaso to become the market leader.
However, Tyvaso is only approved to treat PAH patients with NYHA Class III symptoms – which corresponds to patients with moderate-to-severe cardiac symptoms, characterised by a limitation of activity, who are only comfortable at rest.
Ventavis is approved treat patients with NYHA Classes III and IV symptoms. Class IV represents patients with the most severe form of PAH, who have to remain completely at rest and are unusually confined to a bed or chair.
"[Ventavis is] the only inhaled prostacyclin therapy to show significant patient improvement measured both by exercise capacity and improvement in NYHA functional class," said Dr Jean-Paul Clozel, chief executive at Actelion.
In clinical trials in patients with PAH symptoms of NYHA Class III or IV, the company said that Ventavis significantly increased patient exercise capacity 30 minutes after dosing, after 12 weeks of treatment compared with baseline (p=0.0033), showing an improvement of at least one NYHA class (p=0.03) and no clinical deterioration.
It also improved patients' six minute walk distance at week 12, with a 10% or greater increase in walk distance (p<>