FDA Approvals and Applications Update

On October 22, 2021, the FDA approved Genentech’s SUSVIMO (ranibizumab injection) for wet age-related macular degeneration (AMD) based on positive results from an open-label Phase III study. According to the Genentech press release, SUSVIMO, previously called Port Delivery System with ranibizumab, offers an alternative route of administration for anti-VEGF in the form of an ocular implant that continuously delivers ranibizumab intravitreally. The SUSVIMO implant may be inserted in a single outpatient procedure and refilled every six months. The Phase 3 data indicated that patients treated with SUSVIMO experienced vision improvements equivalent to those receiving monthly ranibizumab injections.

Additionally, on October 8, 2021, J&J’s Janssen announced the submission of a supplemental BLA to the FDA, seeking an expanded indication for STELARA (ustekinumab) to treat pediatric patients with juvenile psoriatic arthritis. According to the press release, the filing was supported by the extrapolation of data from adult and pediatric studies on psoriatic arthritis and plaque psoriasis. STELARA is currently approved for children 6 and older with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease, and adults with moderately to severely active ulcerative colitis.