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Novartis Gets Positive CHMP Opinion for Wet AMD Drug Beovu
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Novartis AG (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for its wet age-related macular degeneration (AMD) drug, Beovu.
The positive CHMP opinion was based on findings from the phase III, global, head-to-head HAWK and HARRIER clinical trials, wherein Beovu demonstrated non-inferiority to Regeneron (REGN - Free Report) and Bayer’s (BAYRY - Free Report) market-leading drug, Eylea (aflibercept), in mean change in best-corrected visual acuity from baseline to year one. Results from the trials showed that approximately 30% of patients treated with Beovu gained at least 15 letters at year one.
In a pre-specified secondary endpoint, fewer patients had intra-retinal fluid and/or sub-retinal fluid at week 16 and year one with Beovu. Additionally, more than half (56% in HAWK and 51% in HARRIER) of patients treated with Beovu 6mg maintained a three-month dosing interval immediately after the loading phase through year one.
A decision from the European Commission is expected in the next three months. The commission takes into account the CHMP’s opinion but is not bound by it.
We remind investors that Beovu was approved by the FDA in October. Per the company, the drug is the first FDA approved anti-VEGF to offer greater fluid resolution as compared to 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.
Novartis’ shares have gained 8.4% in the year so far compared with the industry’s growth of 8.9%.
Wet AMD is the leading cause of severe vision loss and legal blindness in people above the age of 65 in North America, Europe, Australia and Asia. The disease is caused by uncontrolled VEGF, a protein that promotes abnormal blood vessel formation underneath the macula, the area of the retina responsible for sharp, central vision.
Per estimates, wet AMD is impacting roughly 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.
Approval in Europe will strengthen Novartis’ ophthalmology franchise, which also comprises Lucentis. Notably, Lucentis is also approved for wet AMD along with macular edema following retinal vein occlusion and diabetic macular edema, 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.
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Novartis Gets Positive CHMP Opinion for Wet AMD Drug Beovu
Novartis AG (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for its wet age-related macular degeneration (AMD) drug, Beovu.
The positive CHMP opinion was based on findings from the phase III, global, head-to-head HAWK and HARRIER clinical trials, wherein Beovu demonstrated non-inferiority to Regeneron (REGN - Free Report) and Bayer’s (BAYRY - Free Report) market-leading drug, Eylea (aflibercept), in mean change in best-corrected visual acuity from baseline to year one. Results from the trials showed that approximately 30% of patients treated with Beovu gained at least 15 letters at year one.
In a pre-specified secondary endpoint, fewer patients had intra-retinal fluid and/or sub-retinal fluid at week 16 and year one with Beovu. Additionally, more than half (56% in HAWK and 51% in HARRIER) of patients treated with Beovu 6mg maintained a three-month dosing interval immediately after the loading phase through year one.
A decision from the European Commission is expected in the next three months. The commission takes into account the CHMP’s opinion but is not bound by it.
We remind investors that Beovu was approved by the FDA in October. Per the company, the drug is the first FDA approved anti-VEGF to offer greater fluid resolution as compared to 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.
Novartis’ shares have gained 8.4% in the year so far compared with the industry’s growth of 8.9%.
Wet AMD is the leading cause of severe vision loss and legal blindness in people above the age of 65 in North America, Europe, Australia and Asia. The disease is caused by uncontrolled VEGF, a protein that promotes abnormal blood vessel formation underneath the macula, the area of the retina responsible for sharp, central vision.
Per estimates, wet AMD is impacting roughly 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.
Approval in Europe will strengthen Novartis’ ophthalmology franchise, which also comprises Lucentis. Notably, Lucentis is also approved for wet AMD along with macular edema following retinal vein occlusion and diabetic macular edema, 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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This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
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