Sensorion has received acceptance from the European Medicines Agency (EMA) on its Paediatric Investigation Plan (PIP) for Arazasetron (SENS-401) in two indications.
The company’s PIP has been agreed for the treatment of sudden sensorineural hearing loss (SSNHL) and the prevention of ototoxicity caused by cisplatin (CIO) in paediatric patients.
The drug aims to protect and preserve inner ear tissue from damage, preventing progressive hearing impairments. It can be taken orally or via an injection.
Following the agreement, the company will now submit a marketing authorisation application (MAA) in Europe for SENS-401. The drug received orphan drug designation in November 2016.
Orphan drug designation was also granted in the US by the Food and Drug Administration (FDA) for the prevention of platinum-induced ototoxicity in the pediatric population.
Sensorion CEO Nawal Ouzren said: “Indeed, this approval will allow Sensorion to develop SENS-401 for paediatric patients suffering from severe hearing loss (SSNHL) but also in the prevention of ototoxicity caused by cisplatin.
“We think that SENS-401 could be a safe and effective treatment for these severe lesions, a field in which there are substantial unmet medical needs.”
At the start of this year, the company initiated a Phase II trial for SENS-401 that enrolled SSNHL patients.