EU regulator clears Idorsia’s Jeraygo to resistant hypertension
Drug ApprovalPhase 3Clinical Result
Idorsia announced Monday that the European Commission cleared Jeraygo (aprocitentan) to treat adults with resistant hypertension in combination with at least three anti-hypertensive medicines, making it the first and only endothelin receptor antagonist (ERA) approved for the indication.
Touting it as the “first innovative anti-hypertensive drug in 40 years, acting on the endothelin pathway,” Alberto Gimona, head of global clinical development and medical affairs at Idorsia, said Jeraygo stands to be “a key player in patients with resistant hypertension.”
The approval comes on the heels of a positive recommendation by the European drug advisory body in April and is corroborated by the Phase III PRECISION study of 730 patients with difficult-to-control hypertension. In the trial, 12.5 mg and 25 mg doses of Jeraygo showed a significant reduction on sitting systolic blood pressure (BP) at week 4 from baseline versus placebo based on unattended automated office BP measurement. The company noted that the recommended starting dose of Jeraygo is 12.5 mg, which can be upped to 25 mg based on the patient’s tolerance and the need for tighter BP control.
Rough road in the US
The oral drug, marketed as Tryvio in the US, received FDA clearance in March after much turmoil. The therapy was required to carry a boxed warning for embryo-foetal toxicity and made available through a risk evaluation and mitigation strategy programme, which led to a delay in approval from the original target date of December 19 last year. Amidst the deferment, Idorsia’s US partner Johnson & Johnson relinquished its interest in the drug, returning its rights in September.
Furthermore, the company also faced financial setbacks last year, resulting in substantial layoffs and the sale of two late-stage assets to Viatris for $350 million upfront to raise funds. “With aprocitentan, we have a largely unencumbered asset approved in the US and Europe,” remarked André Muller, CEO of Idorsia, adding that they were evaluating “funding options including potential collaborations for the commercialisation…in these two key markets.”
The drugmaker also intends to file marketing applications for Jeraygo in the UK, Canada and Switzerland.
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