Policy & Regulation
US FDA approves Novartis' Beovu injection
10 October 2019 -

The US Food and Drug Administration (FDA) has approved Switzerland-based Novartis' Beovu (brolucizumab) injection intended for the treatment of wet age-related macular degeneration (AMD), it was reported yesterday.

The product, which is also known as RTH258, is now the first anti-VEGF (Vasco Endothelial Growth Factor) to be approved by the regulator.

According to the company, the drug can offer greater fluid resolution compared to aflibercept. It is also said to have the ability to maintain eligible wet AMD patients on a dosing interval of three months immediately after a three-month loading phase with efficacy. The drug is a humanised single-chain antibody fragment, whose structure is claimed to result in a small molecule with potent inhibition of, and high affinity to, all VEGF-A isoforms.

The approval was based on the findings of two phase three trials called HAWK and HARRIER. The Novartis wet AMD candidate delivered non-inferiority in comparison to aflibercept in the two trials in mean change in best-corrected visual acuity (BCVA) in the first year of treatment.