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13 Aug 2024
Admin
News Article

Sandoz Gets US FDA Approval for Enzeevu for nAMD Patients

Sandoz receives US FDA approval for Enzeevu to improve and maintain visual acuity in patients with nAMD

Overview

Sandoz, the global leader in generic and biosimilar medicines, announced that the US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

Words from the CSO: Sandoz

Claire D’Abreu-Hayling, chief scientific officer, Sandoz, said: “nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”

Enzeevu

Enzeevu is a key biosimilar value driver for the company and this approval is a major step in advancing the Sandoz growth strategy by further extending its leading US ophthalmology portfolio.
Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements.

About nAMD

nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.

From the President: Prevent Blindness

Jeff Todd, J.D., president and CEO of Prevent Blindness, said: “As sight disappears, so may a person’s connection to the world. We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer. At this time, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable.”

Behind Approval

The FDA granted approval based on the totality of evidence, including comprehensive analytical and preclinical in vitro study data, as well as clinical data from the Mylight study.
This approval follows the acquisition of the Cimerli (ranibizumab-eqrn) business by Sandoz in the US earlier in 2024.
The acquisition, which included field force employees, strengthened the company’s leading ophthalmology portfolio in the US and created a robust platform to support the anticipated launch of Enzeevu.

About Aflibercept

The active ingredient in Enzeevu is aflibercept.
Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth.
In patients with neovascular age-related macular degeneration (nAMD), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.

Mylight Study

The Mylight study (NCT04864834) was an international, multicenter, randomized, double-masked, 2-arm parallel study in 485 patients with neovascular age-related macular degeneration (nAMD), with a total duration of 52 weeks.
The Mylight study confirmed equivalent efficacy, as well as comparable safety and immunogenicity for Sandoz biosimilar aflibercept and reference medicine Eylea (aflibercept) as per Eylea approved treatment regimen in patients with nAMD.

About Enzeevu

Enzeevu is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD).

About Sandoz

Sandoz is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact.

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