Idorsia files NDA for clazosentan in Japan

Swiss drug developer Idorsia’s (SIX: IDIA) edged up 2.8% to 25.58 francs this morning, as it said it has submitted a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan, a fast-acting, selective endothelin A (ETA) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).

The application is supported by replicated results from the Japanese registration program which consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality events in adult Japanese patients following aSAH.

Dr Satoshi Tanaka, president of Idorsia Pharmaceuticals Japan, commented: “The development of clazosentan has taken many years to bring us to the filing of an NDA and we were very fortunate to not be held back by the COVID-19 pandemic in Japan. The team has worked rapidly to analyze the data and prepare the dossier for the PMDA so that we can bring clazosentan to the patients as soon as possible. We will now work together with the authorities through the regulatory process, and in parallel, prepare the scientific publication and the commercial launch which we hope to see in the first half of 2022.”