Laboratorios Farmacéuticos Rovi, S.A. has been informed of the delay in the decision on the granting of marketing authorisation for Risperidone ISM® by the U.S. Food and Drug Administration (“FDA”). The FDA will be taking a number of actions, including an in-situ inspection of the European production plant where the product is manufactured, located in Madrid (Spain). The grant of the marketing authorisation for Risperidone ISM® by the FDA is subject to the result of this inspection.
The delay in the inspection of the manufacturing facilities has been caused by the restrictions on movement due to COVID-19 and, thus, the FDA has not yet fixed the inspection date.
ROVI filed the application for marketing authorisation for Risperidone ISM® with the FDA on 24 November, 2020. On 24 September, 2021, ROVI received a Complete Response Letter from the FDA with outstanding questions on the Risperidone ISM® dossier. The Company has either answered them or will be answering them in the near future since, in its letter, the FDA recognises that it did not review some of the responses submitted during the evaluation process. ROVI expects its responses to clarify the outstanding questions.
In the Complete Response Letter, the FDA states that, due to the exceptional situation caused by the pandemic which has prevented the inspection from taking place within
the term defined in the Filing Communication Letter, all the responses to outstanding questions will be evaluated in accordance with the timeline described in the “2020 Guidance for Industry Review Timelines for Applicant Reponses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency”, with an estimated review time of 6 months as of the submission of the responses to the questions raised in the Complete Response Letter.
Risperidone ISM® is a novel, once-monthly, injectable antipsychotic, currently in the research phase, for the treatment of schizophrenia, developed and patented by ROVI. As of the first injection, it provides immediate and sustained plasma drug levels of the medicine, without the need for loading doses or supplementation with oral risperidone.
