A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Vabysmo approved for treating two types of macular disease
Genentech’s Vabysmo (faricimab-svoa; injection) has been approved for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME) in adults. The bispecific antibody targets and inhibits the disease pathways in the respective conditions.
Approval of Vabysmo was based on findings from four ongoing Phase 3 randomized, multicenter, double-masked studies. In AVONELLE-X, an extension of the TEANYA and LUCERNE studies, 1,329 patients with AMD were randomized to receive the study drug or aflibercept; in RHONE-X, an extension of the YOSEMITE and RHINE studies, 1,891 patients with DME were randomized 1:1:1 to receive aflibercept every 8 weeks or same-dose Vabysmo every 8 weeks or every 4 weeks. The primary endpoint was change in visual acuity from baseline at 1 year. Findings across the four studies demonstrated that Vabysmo was noninferior to aflibercept.
New indications
Cabenuva label change halves treatment frequency for patients with HIV-1
Viiv Healthcare’s Cabenuva (cabotegravir and rilpivirine; injection) has been granted a label expansion allowing for virologically suppressed adults with HIV-1 infection to receive 6 annual treatments instead of the 12 treatments originally approved in 2021.
Approval of the new labeling was based on findings from the ongoing Phase 3b randomized, open-label, active-controlled, parallel-group ATLAS-2M trial in which 1,045 patients from the indicated population were randomized to receive Cabenuva monthly or every two months. The results demonstrated that 6 annual treatments were noninferior to the 12-treatment option and rates of virologic suppression were similar between the two treatment frequency options.
Cabenuva is manufactured for Viiv by GlaxoSmithKline. The novel regimen was codeveloped by ViiV and Janssen Sciences Ireland. ViiV is the marketing authorization holder for Cabenuva in the US.
Vonvendi gets new indication for treating severe Type 3 von Willebrand disease in adults
Takeda’s Vonvendi (von Willebrand factor [recombinant]; injection) has received a new indication for prophylactic reduction of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD) receiving on-demand treatment.
The approval is based on findings from a Phase 3 prospective, open-label, global study in patients from the indicated population, which showed a reduction of 54.7% in median annualized bleeding rates (ABR), from an historical median ABR of 5.0 (range, 3.0-159.0) to an on-study median ABR of 2.3 (range, 0-157.9).
Vonvendi was originally approved in 2015 as on on-demand treatment for controlling bleeding episodes.