US-based biotechnology company United Therapeutics has obtained an approval from the US Food and Drug Administration (FDA) for the Orenitram (treprostinil) extended-release tablets, indicted for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.
In the FREEDOM-M primary efficacy study, Orenitram has demonstrated improvement in patients' median six-minute walk distance (6MWD) by +23m as compared to patients receiving only placebo. The patients have been administered twice daily with Orenitram.
As the sole vasodilator, the effect of Orenitram on exercise is small and Orenitram has not been shown to add to other vasodilator therapy.
The Phase III FREEDOM-C study and the Phase III FREEDOM-C2 study have not demonstrated a benefit in exercise with median 6MWD at Week 16.
The most common side effects observed with the Orenitram in the clinical studies include headache, nausea, and diarrhea.
United Therapeutics president and COO Dr Roger Jeffs noted that this approval marks the first time that the FDA has approved an orally administered prostacyclin analogue for any disease - and our fifth approval from the FDA for treatment of PAH - supporting our mission of providing a wider choice of PAH therapies for physicians and patients.
"We are grateful for the FDA's thorough review and will continue to build clinical support for the use of Orenitram," Dr Jeffs added.
Orenitram contains the same active ingredient (treprostinil) as Remodulin (treprostinil) injection and Tyvaso (treprostinil) inhalation solution. The drug is indicated for the treatment of PAH (WHO Group 1) to improve exercise capacity
It is available in 0.125mg, 0.25mg, 1mg and 2.5mg strengths. The dose of Orenitram should be increased as tolerated to achieve optimal clinical response. The maximum dose is determined by tolerability.
