EU Approves Idorsia's Jeraygo for Resistant Hypertension

Idorsia recently revealed that the European Commission has approved Jeraygo (aprocitentan) for the treatment of adults with resistant hypertension, who require a combination of at least three anti-hypertensive medications. This makes Jeraygo the first and only endothelin receptor antagonist (ERA) authorized for this condition. Alberto Gimona, head of global clinical development and medical affairs at Idorsia, highlighted that Jeraygo is the first innovative drug in 40 years targeting the endothelin pathway and is set to be a significant player for patients struggling with resistant hypertension.

The approval follows a favorable recommendation from the European drug advisory body in April and is supported by the Phase III PRECISION study, which involved 730 patients with difficult-to-control hypertension. The study demonstrated that doses of 12.5 mg and 25 mg of Jeraygo significantly reduced sitting systolic blood pressure (BP) at week 4 from baseline compared to placebo, using unattended automated office BP measurement. Idorsia recommends an initial dose of 12.5 mg, with the possibility of increasing it to 25 mg based on the patient's tolerance and need for more stringent BP control.

In the United States, the drug is marketed under the name Tryvio. The FDA approved it in March, although the approval process faced considerable challenges. The therapy required a boxed warning for embryo-foetal toxicity and had to be made available through a risk evaluation and mitigation strategy program, which delayed its approval from the original target date of December 19 of the previous year. During this postponement, Idorsia's U.S. partner, Johnson & Johnson, decided to relinquish its interest in the drug, returning its rights in September.

Additionally, Idorsia encountered financial difficulties last year, resulting in significant layoffs and the sale of two late-stage assets to Viatris for $350 million upfront to secure funds. CEO André Muller stated that with aprocitentan, Idorsia now possesses a largely unencumbered asset approved in both the U.S. and Europe. He mentioned that the company is exploring various funding options, including potential collaborations for marketing in these crucial markets.

Idorsia also plans to submit marketing applications for Jeraygo in other regions, including the UK, Canada, and Switzerland.