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Novartis' (NVS) Wet AMD Drug Beovu Obtains FDA Approval

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Swiss pharma giant Novartis AG (NVS - Free Report) announced that the FDA approved its ophthalmology drug Beovu (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD).

Per the company, Beovu is the first FDA approved anti-VEGF to offer greater fluid resolution as compared to Regeneron (REGN - Free Report) and Bayer’s (BAYRY - Free Report) market-leading drug Eylea as well as the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy.

The FDA approval was based on encouraging data from the phase III HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferiority compared to Eylea in mean change in best-corrected visual acuity (BCVA) at year one (week 48). Beovu also demonstrated greater reductions in central subfield thickness (CST, a key indicator of fluid in the retina) as early as week 16 and at one year versus Eylea.

Data from both trials showed that at year one, more than half of patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER).

Novartis’ shares have lost 0.5% in the year so far, in line with the industry’s decline.

Wet AMD is a leading cause of blindness, affecting more than 20 million people worldwide.  However, frequent injections are a common reason, due to which patients drop out of the treatment.

Beovu is expected to pose stiff competition to Eylea as it is the first drug to offer less frequent dosing in the first year of therapy while maintaining its effectiveness. The drug’s potential to treat patients with quarterly injections is a major positive and should enable it to capture market share.

The FDA approval of Beovu will strengthen Novartis’ ophthalmology franchise, which comprises Lucentis.

We note that Lucentis is also approved for wet AMD along with macular edema following retinal vein occlusion (RVO) and diabetic macular edema (DME), among others.

Novartis has a collaboration agreement with Roche (RHHBY - Free Report) for Lucentis. Roche retains commercial rights for the drug in the United States while Novartis has exclusive commercial rights for the rest of the world.

Approval of new drugs bodes well for Novartis as it looks to strengthen its core pharmaceutical business.

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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