The United Kingdom’s Medicines and Healthcare products Regulatory Agency has determined Biosplice’s application for approval of Lorecivivint to be complete and valid and has accepted the dossier for formal assessment, starting the regulator’s review timetable.
Lorecivivint, also known as LOR, is a first-in-class small-molecule suspension intended for intra-articular injection into the knee one to two times per year.
According to the company, LOR has been evaluated in eleven clinical trials, and the clinical program showed statistically and clinically significant improvements in medial joint structure, pain and function with a consistent safety profile.
The company highlights disease modification primarily in its Phase 3 OA-07 trial, which it says demonstrated improvement in medial joint space width on imaging over multiple years.
Biosplice intends to submit an application for Lorecivivint to the European Medicines Agency later this month and has submitted for approval in the United States; Lorecivivint remains an investigational medicine not approved by the MHRA, the FDA or any other regulatory authority.
