European Medicines Agency (EMA) approves safety label update for Novartis Beovu

  • Novartis worked with the EMA to update the Beovu (brolucizumab) label to guide physicians in their treatment of wet AMD  
  • The update includes the additional characterization of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation1
  • 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
  • Novartis is confident that Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile 

Basel, September 14, 2020 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP), has approved an update to the Beovu (brolucizumab) Summary of Product Characteristics (SmPC) to include additional information regarding retinal vasculitis and retinal vascular occlusion1. Typically, these events occurred in the presence of intraocular inflammation. This approval follows Novartis’  announcement  that it would pursue worldwide label updates after a review and further characterization of post-marketing safety events reported to Novartis.

The update to the EU label includes the addition of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation under "Special warnings and precautions for use" (section 4.4) and "Undesirable effect" (section 4.8). The label notes that patients developing these events should discontinue treatment and the events should be promptly managed1.

"This label update is one of the many efforts Novartis is taking to help physicians make informed decisions," said Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals. "Novartis is committed to fully understanding and transparently communicating the safety profile of Beovu. To this purpose, we have established a coalition, which is a fully dedicated internal team collaborating with top global experts to examine the root cause, risk factors, mitigation and potential treatment recommendations."

The label update is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein1. Beovu is now approved for the treatment of wet AMD in more than 40 countries, including in the US2, EU1, UK1, Japan3, Canada4 and Australia5.

About Beovu (brolucizumab)
Beovu (brolucizumab, also known as RTH258) is the most clinically advanced humanized single-chain antibody fragment (scFv)6-8. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics8-10.

The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms9. Beovu is engineered to deliver a high concentration of drug, thus providing more active binding agents6-8. In preclinical studies, Beovu inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction9-11. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema12. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability12.

Beovu is approved in more than 40 countries, including in the US2, EU1, UK1, Japan3, Canada4 and Australia5, based on the results of the HAWK and HARRIER clinical trials.

About the HAWK and HARRIER studies
With more than 1,800 patients across nearly 400 centers worldwide, HAWK (NCT02307682) and HARRIER (NCT02434328) are the first global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy of Beovu at week 48 using an innovative q12w/q8w regimen, with a majority of patients on q12w immediately following the loading phase6,7. Both studies are 96-week prospective, randomized, double-masked multi-center studies and part of the Phase III clinical development of Beovu6,7. The studies were designed to compare the efficacy and safety of intravitreal injections of brolucizumab 6 mg (HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg in patients with wet AMD6,7. The most common adverse events (>=5% of patients) with Beovu were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain6,7.

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