FDA approves intravenous version of J&J's Uptravi to prevent treatment interruptions

The FDA has approved an injectable version of Johnson & Johnson’s pulmonary arterial hypertension (PAH) drug Uptravi. J&J developed the formulation to allow patients to continue to receive treatment if they are temporarily unable to take the oral version of the drug.

Abrupt interruptions in the use of some PAH drugs, such as GlaxoSmithKline’s Flolan, are associated with rebounds in PAH that can result in dizziness, asthenia, increased dyspnoea and ultimately death. An assessment of data from the pivotal GRIPHON study found temporary interruptions in the use of Uptravi were well tolerated and manageable. However, with re-titration with oral Uptravi potentially being needed after the interruption, J&J sees value in maintaining a consistent dose level.

That thinking led J&J to develop an intravenous formulation of Uptravi. If a patient is hospitalized for elective surgery or otherwise unable to take oral therapies, the intravenous formulation could allow them to continue treatment at the same dose level and avoid the need to re-titrate the oral product later.

The FDA approved the intravenous formulation on the strength of data from a 20-subject clinical trial. Actelion, which J&J bought for $30 billion in 2017, designed the study to show the effect of switching patients from oral Uptravi to the intravenous formulation and back again. Subjects received three infusions of Uptravi across two days.

Fifteen patients had adverse events, but most were mild, and none caused the subjects to drop out of the study. Exposure to the active metabolite of Uptravi stayed at a similar level following the switch to intravenous dosing and no symptomatic changes in blood pressure were reported.

The approval of the intravenous formulation of Uptravi gives J&J a way to help maintain the growth of the drug. Global sales grew almost 34% last year to top $1 billion. J&J maintained the trajectory over the first half of 2021, when sales increased 16%.