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More than six months after demonstrating that brolucizumab was superior to Eylea for the treatment of neovascular age-related macular degeneration, Swiss pharma giant Novartis is one step closer to potentially carving out a significant chunk of market share from the Regeneron drug.

On Monday, Novartis said the U.S. Food and Drug Administration (FDA) accepted the company’s Biologics License Application for brolucizumab for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. In order to bring the treatment to patients as quickly as possible, Novartis said it used a priority review voucher to expedite review. If the medication is approved, Novartis said it anticipates a launch of the drug by the end of 2019.

Brolucizumab is a humanized single-chain antibody fragment (scFv) designed to inhibit vascular endothelial growth factor (VEGF). Approximately 20 to 25 million people are affected by nAMD, also known as wet AMD, a leading cause of blindness worldwide. In the United States, it is estimated that between 1.5 and 1.75 million people will be living with wet AMD.

Brolucizumab is something of a successor to Lucentis, the first anti-VEGF monoclonal antibody designed specifically for the treatment of the wet form of AMD. Lucentis was jointly developed by Novartis and Roche. Last fall, analysts with GlobalData said with the launch of brolucizumab, “Novartis will offset the losses to Eylea and regain dominance in the AMD market.” If brolucizumab launches by the end of this year, the GlobalData analysts predict the drug will hit blockbuster status by 2021 and will become “the highest selling drug by 2026 in the wet AMD space.” GlobalData speculates that at its peak, brolucizumab can bring in between $4.1 billion and $7 billion. At the same time, Eylea sales will likely drop from its peak of $2.6 billion to $1.5 billion by 2026, according to GlobalData.”


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Fabrice Chouraqui, president of Novartis Pharmaceuticals, said the acceptance of the BLA is an important milestone in the company’s efforts to “reimagine the treatment journey for people with wet AMD and their caregivers.” Chouraqui said Novartis is looking forward to the potential of bringing a new option for people with wet AMD.

The BLA is primarily based on Phase III data from the HAWK and HARRIER trials. In the two year studies, brolucizumab met its primary endpoint of non-inferiority versus Eylea (aflibercept) in best-corrected visual acuity. Novartis said brolucizumab exhibited superiority in key retinal outcomes at 48 weeks. Data from the studies showed that brolucizumab continued to exhibit superiority at 96 weeks in the reduction of retinal fluid, an important marker in nAMD disease activity. The HAWK and HARRIER study findings demonstrated that fewer patients with nAMD who were treated with brolucizumab had intra-retinal fluid (IRF) and/or sub-retinal fluid than those patients who were treated with Eylea at 96 weeks. HAWK and HARRIER are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 starting with a 12-week dosing regimen, Novartis said.



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