FDA approves Idorsia’s once-daily antihypertensive Tryvio
2024-03-20
临床3期上市批准临床2期并购临床结果
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来源: Pharmaceutical Technology
Idorsia plans to launch the hypertension therapy Tryvio in the US in H2 2024. Image Credit: JHVEPhoto / Shutterstock.
Switzerland-based Idorsia has received approval from the US Food and Drug Administration (FDA) for the use of Tryvio (aprocitentan) as a combination treatment for hypertension in patients whose blood pressure is inadequately controlled with other antihypertensive drugs.
The news comes a few months after the company signed a deal with Johnson & Johnson to reacquire global rights for Tryvio. Idorsia agreed to pay up to Sfr306m ($343.5m) contingent on the EU and US approvals of the drug.
Tryvio is an endothelin receptor antagonistendothelin receptor antagonist, which inhibits the binding of endothelin, a vasoconstrictive peptide, to its receptors on smooth muscle cells which results in vasodilation, ultimately, leading to a reduction in blood pressure. Idorsia plans to launch Tryvio in the US in H2 2024.
The approval was based on the Phase II and Phase III trial data. Tryvio showed a reduction in blood pressure for up to 48 weeks in the Phase III PRECISION trial (NCT03541174). One of the main side effects of the drug was fluid retention, which can cause rapid weight gain and stiffness of joints.
The global market for resistant hypertension is expected to be worth $895m by 2030, according to a GlobalData market analysis. The main competitor for Tryvio for this indication is expected to be AstraZeneca’s baxdrostat. While Tryvio will have the first-to-market advantage, baxdrostat is expected to generate $506m in sales in 2030, compared to $141m estimated for Tryvio during the same period.
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来源: Pharmaceutical Technology
GlobalData is the parent company of Pharmaceutical Technology.
AstraZeneca added baxdrostat to its portfolio as part of the $1.8bn acquisition of CinCor Pharma in January 2023. Baxdrostat is a selective aldosterone synthase inhibitoraldosterone synthase inhibitor. The drug is being evaluated in a Phase III BaxHTN trial (NCT06034743). The study is expected to enrol up to 720 participants with resistant hypertension taking two or more hypertensives to control their blood pressure.
Another drug in development for treating resistant hypertension is Novartis’ XXB750, a natriuretic peptide receptor 1 (NPR1) agonist. The drug is being evaluated in a Phase II trial (NCT06034743). The study is expected to enrol up to 170 participants and will be completed in September 2024.
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