Novartis gets FDA’s approval for Beovu for AMD patients

Novartis has received FDA approval for Beovu, the only anti-VEGF in wet AMD recommended to maintain eligible patients on up to three-month dosing intervals immediately after the loading phase with no compromise in efficacy, for AMD patients, which are in risk from causes blindness and loss of independence.

Dr. Pravin U. Dugel, who was the principal investigator of the HAWK clinical trial said that Beovu meets goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid.

He said that with Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. “Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD,” he said.

Novartis said in the press release that the approval of BEOVU was based on findings from the Phase III HAWK and HARRIER clinical trials, in which BEOVU demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one. In HAWK and HARRIER, BEOVU showed greater reduction in central subfield thickness (CST) as early as week 16 and at year one, and fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF). Retinal fluid is a key marker of disease activity.

Marie-France Tschudin, President, Novartis Pharmaceuticals, said that the product labels of existing treatments state that they are not as effective when dosed every 12 weeks. She said that Bevou is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness, and that this gives more time for wet AMD patients to focus on what’s important in their lives.