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US FDA and EMA accept application for Novartis’ Beovu to treat DME

Diabetic macular edema captis executive search management consulting leadership board services

The US Food and Drug Administration (FDA) has approved biologics license application (sBLA) and the European Medicines Agency (EMA) has validated the type-II variation application for Novartis’ Beovu (brolucizumab) to treat patients with diabetic macular edema (DME).

The US Food and Drug Administration (FDA) has approved biologics license application (sBLA) and the European Medicines Agency (EMA) has validated the type-II variation application for Novartis’ Beovu (brolucizumab) to treat patients with diabetic macular edema (DME).

Additionally, the application for Beovu was also accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for treatment of DME.

DME is a common microvascular complication in diabetic patients, which will eventually lead to blindness in adults.

It is the leading cause of blindness in adults with type 1 and type 2 diabetes.

Addressing the burden of frequent treatment schedules and improving fluid resolution are the unmet needs in DME.

The company stated that the regulatory applications are based on the year one data obtained from the Phase III KESTREL and KITE studies which compared the safety and efficacy of Beovu six mg with aflibercept two mg in DME patients.

In the trial, Beovu met the primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline compared to aflibercept.

It has also showed potential for fluid resolution in more DME patients with less injections and favourable benefit-risk profile in these studies.

Novartis claimed that the two-year KESTREL and KITE studies are the first pivotal trials to evaluate an anti- vascular endothelial growth factor (VEGF) treatment on six-week dosing intervals.

Novartis Ophthalmology global development unit head and senior vice president Jill Hopkins said: “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.”

The company expects the regulatory decisions in the US and Europe for Beovu to treat DME to come in mid of 2022.

If approved, DME would be the second indication for Beovu after its approval by FDA and European Commission to treat wet age-related macular degeneration in October 2019 and February 2020, respectively.

This is not a CAPTIS article. Originally, it was published here.