Novartis Terminates Merlin Study Despite Achieving Primary Endpoint

By Olivia Bugault

Novartis AG said on Friday evening that the phase 3 of its Merlin trial which assesses the efficacy and safety of Beovu has met its primary endpoint, but that it will end the study due to safety concerns.

In the two-year study that began in the second half of 2018, six milligrams of Beovu were given every four weeks to patients with age-related wet macular degeneration, an eye disease that can lead to vision loss. severe, Novartis said.

Although the study met its primary endpoint – of “non-inferiority of change in best corrected visual acuity from baseline” – and its secondary endpoint of “superiority in some anatomical features In the first year compared to the drug aflibercept, the Swiss pharmaceutical giant announced the early termination of the Merlin study. He also said he was terminating two other studies, Raptor and Raven, evaluating the efficacy and safety of Beovu in retinal vein occlusion.

“In this [Merlin] study evaluating one dose every four weeks, Beovu was associated with higher rates of IOI [Idiopathic orbital inflammatory] including retinal vasculitis and retinal vascular occlusion compared to aflibercept, ”the company said.

Novartis said doctors should not use Beovu 6 mg at intervals less than two months beyond the first three doses.

Write to Olivia Bugault at [email protected]

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