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Novartis' (NVS) Beovu Gets FDA Approval for Label Update

Zacks Equity Research

Novartis AG NVS announced that the FDA has approved a label update for ophthalmology drug, Beovu (brolucizumab), to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.

The update to the label includes the addition of a sub-section dedicated to retinal vasculitis and/or retinal vascular occlusion under ‘Warnings and Precautions.’ It also specifies that these adverse reactions are part of a spectrum of intraocular inflammation rates from the phase III HAWK & HARRIER studies.

The label update comes after Novartis decided to evaluate post-marketing cases reported as severe vision loss, retinal artery occlusion and/or vasculitis with Beovu.

Thereafter, the company initiated its own internal review of these post-marketing safety case reports, including the establishment of an external Safety Review Committee (SRC). The SRC recently issued a report of its unmasked, independent analysis of HAWK & HARRIER adverse events, wherein it found that cases similar to those reported post marketing were present in the HAWK & HARRIER clinical studies.

We remind investors that Beovu was approved by the FDA in 2019 for the treatment of wet age-related macular degeneration (AMD), based on findings from the late-stage HAWK and HARRIER studies, in which the drug demonstrated non-inferiority compared to Regeneron REGN and Bayer’s BAYRY Eylea.

The drug was touted to pose stiff competition to Eylea and Roche’s RHHBY Lucentis with its less frequent dosing schedule. However, a few cases of vasculitis casted a shadow on the drug’s safety profile.

The stock has lost 4.8% in the year so far against the industry’s gain of 1.3%.


After having gone through a series of restructuring moves, Novartis looks to strengthen its core pharma business. Solid performance of key drugs like Cosentyx and Entresto and contributions from gene therapy, Zolgensma, have boosted performance, lately.

New launches like Piqray and Beovu too were projected to boost growth. However, it remains to be seen the growth trajectory Beovu takes up following this label update.

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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