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Friday, May 28, 2021

Novartis terminates Beovu program on safety considerations

 

  • Beovu (brolucizumab) met MERLIN’s primary endpoint of non-inferiority in change in best corrected visual acuity from baseline and superiority on anatomical secondary endpoints at year one versus aflibercept when given every four weeks following the loading phase1

  • In this study evaluating every four week dosing, Beovu was associated with higher rates of IOI including retinal vasculitis and retinal vascular occlusion versus aflibercept1

  • Patient safety is of paramount importance and led Novartis to decide on early termination of the MERLIN study

  • Novartis has also decided on early termination of the RAPTOR and RAVEN studies, which assessed the efficacy and safety of brolucizumab in retinal vein occlusion, and included six initial monthly injections

  • Novartis has proactively communicated these data to health authorities and will pursue an update to the Beovu prescribing information globally regarding every four week dosing

  • When used on a two- to three-month interval following the loading phase, Beovu remains an important and effective treatment option for appropriate patients with wet AMD2,3

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