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Novartis’ Brolucizumab Filing Approval for Patients with Wet AMD

Last week the drug manufacturer Novartis announced that the United States Food and Drug Administration (FDA) had approved a filing for Biologics License Application for a new medication brolucizumab (also known by its study name RTH258).1 This medication is for the treatment of wet age-related macular degeneration and has been given a priority review voucher for expedited FDA review, in order to make the medication available as quickly as possible. If approved, brolucizumab could be available as early as the end of 2019.

Brolucizumab clinical trials

The expedited FDA review of brolucizumab is based on two separate phase III drug trials of the biologic agent. Both studies were randomized, double-blind, multi-center trials.1

  • Phase III trials test how effective a study medication is, and continue to assess the safety of medications on larger numbers of patients.2
  • Randomized trials are trials where the patients are randomly selected to receive either the study medication or the current standard of care therapy.3
  • A double-blind study is a study where neither the patient nor the researchers know which medication (the study drug or the standard of care drug) the study patient is getting.3
  • Multi-center trials happen at more than one study location or hospital.3

Eylea

Both studies found that brolucizumab was a superior product to the currently used medication Eylea (aflibercept) at both reducing disease activity and reducing retinal fluid, even at 48 weeks of use. Brolucizumab was also found to be non-inferior to aflibercept at improving visual acuity.1

Brolucizumab

Brolucizumab is an injectable biologic agent that is referred to as a single-chain antibody fragment.1 Biologic agents are created from living cells, and unlike traditional medications, they are large, complex molecules. Brolucizumab is one of the smaller biologic agents which has many benefits in treating certain conditions, including better tissue penetration and superior drug delivery characteristics.1

How does it work?

Brolucizumab works by inhibiting vascular endothelial grown factor (VEGF), which has been shown to resolve retinal edema and inhibit the grown of neovascular lesions. In clinical trials, brolucizumab was administered every 8-12 weeks, after a 3-month loading period.1

Brolucizumab approval

If the FDA approves brolucizumab, it will give patients with wet age-related macular degeneration a new approach to therapy and hope for prolonged preservation of their eyesight. Research on biologic agents continues to open new doors to better treatment and new paths to more effective, targeted therapies.

  1. Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD | Novartis. Novartis. https://www.novartis.com/news/media-releases/novartis-announces-fda-filing-acceptance-and-priority-review-brolucizumab-rth258-patients-wet-amd. Published 2019. Accessed April 27, 2019.
  2. Step 3: Clinical Research. Fda.gov. https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm. Published 2019. Accessed April 27, 2019.
  3. Glossary of Terms. Fda.gov. https://www.fda.gov/ForPatients/ClinicalTrials/ucm410359.htm. Published 2019. Accessed April 27, 2019.

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