FDA approvals

FDA approves Orenitram for treatment of PAH

United Therapeutics Corp. announced that the FDA approved an extended-release version of treprostinil for treatment of pulmonary arterial hypertension.

Treprostinil in its extended-release tablet form will be sold under the brand name Orenitram. It is approved for the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity in WHO Group I patients. Treprostinil is already marketed in injection form as Remodulin and in inhalation solution form as Tyvaso.

According to a company press release, in the primary efficacy study, FREEDOM-M, patients assigned Orenitram twice daily improved their median 6-minute walk distance by +23 m compared with those assigned placebo (P=.013). Two other phase 3 studies, FREEDOM-C and FREEDOM-C2, did not show a benefit in 6-minute walk distance for those assigned Orenitram at 16 weeks (FREEDOM-C, 11 m; P=.072; FREEDOM-C2, 10 m; P=.089), according to the release.

The most common adverse events reported during the studies by those assigned Orenitram were headache, nausea and diarrhea, according to the release.

“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,” Roger Jeffs, PhD, president and chief operating officer of United Therapeutics, said in the press release.

United Therapeutics Corp. announced that the FDA approved an extended-release version of treprostinil for treatment of pulmonary arterial hypertension.

Treprostinil in its extended-release tablet form will be sold under the brand name Orenitram. It is approved for the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity in WHO Group I patients. Treprostinil is already marketed in injection form as Remodulin and in inhalation solution form as Tyvaso.

According to a company press release, in the primary efficacy study, FREEDOM-M, patients assigned Orenitram twice daily improved their median 6-minute walk distance by +23 m compared with those assigned placebo (P=.013). Two other phase 3 studies, FREEDOM-C and FREEDOM-C2, did not show a benefit in 6-minute walk distance for those assigned Orenitram at 16 weeks (FREEDOM-C, 11 m; P=.072; FREEDOM-C2, 10 m; P=.089), according to the release.

The most common adverse events reported during the studies by those assigned Orenitram were headache, nausea and diarrhea, according to the release.

“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,” Roger Jeffs, PhD, president and chief operating officer of United Therapeutics, said in the press release.

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