Novartis announces that FDA brolucizumab injection approves to be noninferior to aflibercept in Phase III studies

Novartis AG (NYSE:NVS; SIX:NOVN) has announced that the U.S. Food and Drug Administration (FDA) has approved brolucizumab (“Beovu”) injection (also known as RTH258) for the treatment of wet age-related macular degeneration (AMD).  According to the company, the product is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept “and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy”.

 

The results of the study were conducted by two Phase III trials: HAWK (NCT02307682) and HARRIER (NCT02434328) recruited 1,817 patients at 408 sites in North, Central, and South America; Europe; Asia; Australia; and Japan.  The results of the study was reported in the AAO journal (Ophthalmology) outlining that at week 48 of the study, each brolucizumab arm demonstrated noninferiority to aflibercept in BCVA change from baseline (least squares [LS] mean, + 6.6 [6 mg] and +6.1 [3 mg] letters with brolucizumab vs. +6.8 letters with aflibercept [HAWK]; +6.9 [brolucizumab 6 mg] vs. + 7.6 [aflibercept] letters [HARRIER]; P<0.001 for each comparison). Greater than 50% of brolucizumab 6 mg – treated eyes were maintained on q12w dosing through week 48 (56% [HAWK] and 51% [HARRIER]). At week 16, after identical treatment exposure, fewer brolucizumab 6 mg – treated eyes had disease activity versus aflibercept in HAWK (24.0% vs. 34.5%; P= 0.001) and HARRIER (22.7% vs. 32.2%; P= 0.002). Greater central subfield thickness reductions from baseline to week 48 were observed with brolucizumab 6 mg versus aflibercept in HAWK (LS mean – 172.8 µm vs. -143.7 µm; P=0.001) and HARRIER (LS mean – 193.8 µm vs. – 143.9 µm; P< 0.001).  Anatomic retinal fluid outcomes favored brolucizumab over aflibercept. Overall, adverse event rates were generally similar with brolucizumab and aflibercept.

 

According to Dr. Pravin U. Dugel, MD, clinical professor of Roski Eye Institute, Keck School of Medicine, University of Southern California and principal investigator of the HAWK clinical trial stated 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”.

123 thoughts on “Novartis announces that FDA brolucizumab injection approves to be noninferior to aflibercept in Phase III studies”

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