Novartis announced on Wednesday that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation application for Beovu(R) (brolucizumab) 6mg for the treatment of diabetic macular edema (DME), the leading cause of blindness in adults in developed countries.

Additionally, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an application for Beovu in the treatment of DME. Regulatory decisions for Beovu in DME are expected in mid-2022 for the US and Europe.

If approved, DME would be the second indication for Beovu following its approval for wet age-related macular degeneration in October 2019 (FDA) and February 2020 (European Commission).

'People living with diabetes often need to manage multiple comorbidities related to diabetes and there is a significant need to provide better disease management. If approved, Beovu has the potential to provide better fluid resolution and fewer injections during the loading phase and throughout maintenance treatment,' said Jill Hopkins, Novartis Pharmaceuticals' SVP and global development unit head, Ophthalmology. 'We look forward to bringing this potential new treatment option that may help to address unmet needs in the DME patient population.'

The company said that the regulatory applications are based on year one data from the Phase III, randomised, double-masked KESTREL and KITE studies, which met their primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline versus aflibercept at year one.