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Novartis' Eye Drug's Safety Label Update Approved by EMA

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Novartis AG (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has approved an update to Beovu’s (brolucizumab) label to guide physicians in their treatment of wet age-related macular degeneration (wet AMD). We note that Beovu is approved for the treatment of wet AMD by the FDA and the European Commission (EC).

Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision.

The update includes the additional characterization of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation. The label notes that patients developing these events should discontinue treatment and the events should be promptly managed.

Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of these adverse events.

Shares of the company have decreased 5% year to date against the industry’s growth of 0.3%.

During the second quarter of 2020, the FDA also approved a label update of Beovu to include additional safety information. The update included characterization of adverse events — retinal vasculitis and retinal vascular occlusion — as part of the spectrum of intraocular inflammation observed in the HAWK and HARRIER studies and noted in the original prescribing information.

Novartis is confident that Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile. However, sales of the drug might be affected following the label update.

Zacks Rank &Stocks to Consider

Novartis currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (EBS - Free Report) , Bio Techne Corp (TECH - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) . While Emergent sports a Zacks Rank #1 (Strong Buy), Bio Techne and Alimera carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $4.03 to $6.07 for 2020 and from $5.07 to $6.17 for 2021 over the past 60 days. Shares of the company have increased 93.1% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 12.7% year to date.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 26.3% year to date.

 

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