Novartis Korea said Beovu (ingredient: brolucizumab), a treatment for wet, age-related macular degeneration (AMD), obtained the Ministry of Food and Drug Safety approval for expanded indication to also treat diabetic macular edema on Aug. 4.
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Novartis has reported positive year two (week 100) data from the nPhase III KESTREL clinical trial of Beovu (brolucizumab) to treat nindividuals with visual impairment that occurs due to diabetic macular noedema (DME).
Novartis has announced the first interpretable results from year two (week 100) of the Phase III KESTREL study. KESTREL assessed the safety and efficacy of Beovu® (brolucizumab) 6mg in patients with visual impairment due to diabetic macular edema (DME). Results from year two confirmed the visual acuity gains, fluid reduction findings and safety profile from year one, while addressing the burden of frequent treatments for DME patients.
Novartis have announced the first interpretable results from nyear two (week 100) of the Phase III KESTREL study. KESTREL assessed thensafety and efficacy of Beovu (brolucizumab) 6 mg in patients with nvisual impairment due to diabetic macular edema (DME).
Novartis announced 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 (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME). 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.
Novartis announced positive results from two phase III clinical trials assessing Beovu (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). Year two of the pivotal KITE trial evaluated Beovu on up to 16-week dosing intervals, and the one-year KINGFISHER study evaluated Beovu dosed every four weeks. Both trials demonstrated an overall well-tolerated safety profile.