* Idorsia receives approval from the European Commission (EC) for JERAYGO((TM))

    (aprocitentan) as the first and only endothelin receptor antagonist (ERA)
    for the treatment of resistant hypertension.
  * JERAYGO is a new oral antihypertensive therapy - the first in almost 40
    years - that is working via a new therapeutic pathway.

Allschwil, Switzerland - July 1, 2024
Idorsia Ltd (SIX: IDIA) announced today that the European Commission (EC) has
approved JERAYGO((TM)) (aprocitentan) for the treatment of resistant hypertension
in adult patients in combination with at least three antihypertensive medicinal
products.(1) The recommended dose is 12.5 mg orally once daily. The dose can be
increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in
need of tighter blood pressure (BP) control.(1)
Hypertension is one of the leading causes of cardiovascular disease worldwide,
impacting an estimated 1.3 billion people globally.(2) Approximately 10% of
these people have uncontrolled BP, despite receiving at least three
antihypertensive medications from different classes, at optimal doses and they
are categorized in hypertension guidelines as having resistant
hypertension.(3)(,)(4)
Prof. Krzysztof Narkiewicz, MD, PhD, Head of the Department of Hypertension and
Diabetology, Medical University of Gdansk, Poland, commented:
"JERAYGO is an oral antihypertensive therapy that is tackling a new therapeutic
pathway - the endothelin system. JERAYGO has demonstrated clinically meaningful
rapid and long-term reduction in blood pressure. What I was particularly
impressed with, this effect was shown in patients with resistant hypertension,
whose blood pressure remained uncontrolled despite receiving at least three
antihypertensive medications as background therapy. In Europe, there are
millions of patients with resistant hypertension, and they are at a higher risk
of heart attack, heart failure, stroke, end-stage renal disease and death due to
their high blood pressure. With JERAYGO, doctors now a have an effective new
treatment option to help control blood pressure in these patients."
Alberto Gimona, MD, Head of Global Clinical Development & Medical Affairs,
commented:
"We are very proud to have gained approval for JERAYGO, the first innovative
anti-hypertensive drug in 40 years, acting on the endothelin pathway, which we
believe is a key player in patients with resistant hypertension. We have seen a
clinically meaningful and consistent blood pressure lowering across blood
pressure measurement methodologies and in subgroups of patients with serious
comorbidities - for example in patients with chronic kidney disease. We also saw
a marked reduction in albuminuria with JERAYGO as evidenced by a decrease in
baseline UACR. I'm very pleased that the wealth of data we have generated with
JERAYGO is well reflected in the label. We will now work to expand marketing
authorization by also applying for JERAYGO approval in the UK, Canada, and
Switzerland."
André Muller, Chief Executive Officer of Idorsia commented:
"With aprocitentan, we have a largely unencumbered asset approved in the US and
Europe. We continue to carefully evaluate all our funding options including
potential collaborations for the commercialization of aprocitentan, while
preparing to make aprocitentan available in these two key markets."
About the Phase 3 PRECISION study(1)(,5)
The efficacy of aprocitentan was evaluated in one randomized, double-blind (DB),
placebo-controlled Phase 3 multicenter study. Patients with uncontrolled blood
pressure (systolic blood pressure (SBP) >=140 mmHg) despite the use of at least
three antihypertensive medicinal products and following exclusion of pseudo-
resistant hypertension (e.g., white coat effect, inappropriate blood pressure
measurement, secondary causes of hypertension) were considered to have resistant
hypertension. The patients were switched to standardized background
antihypertensive therapy consisting of an angiotensin receptor blocker
(valsartan 160 mg), a calcium channel blocker (amlodipine 5 or 10 mg), and a
diuretic (hydrochlorothiazide 25 mg) throughout the study. Patients with
concomitant use of beta-blockers continued this treatment throughout the study,
in addition to the standardized background antihypertensive therapy and study
treatment. A total of 730 patients received either aprocitentan 12.5 mg,
aprocitentan 25 mg, or placebo once daily during the initial 4-week DB treatment
(part 1). Thereafter, patients received aprocitentan 25 mg once daily during the
32-week single-blind treatment (part 2). At the end of the 32 weeks, patients
were re-randomized to receive either aprocitentan 25 mg or placebo, once daily,
during the 12-week double-blind withdrawal (DB-WD) treatment (part 3).
The primary efficacy endpoint was the change in sitting SBP (SiSBP) from
baseline to Week 4 during DB treatment (part 1), measured at trough by
unattended automated office blood pressure (uAOBP). The key secondary endpoint
was the change in SiSBP measured at trough by uAOBP from DB-WD baseline (Week
36) to Week 40 (part 3).
Patients had a mean age of 61.7 years (range 24 to 84 years; 34.1% were >= 65 and
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