Vabysmo Prefilled Syringes Get Approval
On July 5, 2024, the U.S. Food and Drug Administration (FDA) approved a new formulation of Genentech’s Vabysmo™ (faricimab-svoa) injection in single-dose prefilled syringes. This formulation will have the same three indications for neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Vabysmo is a bispecific antibody that works by blocking the activity of neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), to decrease blood seepage and inflammation in the eyes by strengthening blood vessels. Approximately 1.5 million Americans have nAMD, which distorts central vision. It is caused by abnormal growth of blood vessels in the eye’s macula, affecting the parts of the retinas responsible for clear central vision. Roughly 40% of cases involve both eyes at diagnosis, but up to 20% of patients progress to bilateral involvement each year. Approximately 750,000 patients have DME, a complication resulting from diabetes, which results from swelling due to blood seeping from damaged blood vessels in the macula. DME is more likely to affect both eyes with as many as 80% of patients affected at diagnosis. Around 16.4 million Americans are affected by RVO. It occurs when large or small veins in the eye become blocked by a blood clot leading to swelling in the macula. If untreated, all three conditions can lead to vision loss. The prefilled syringes are preservative-free (PFS) and a ready-to-use version that contains the same 6mg dose of Vabysmo as the single-dose vial version. It is to be administered by intravitreal injection into the affected eye(s) by a healthcare professional. After patients receive their first four treatments at four-week intervals, dosing can be adjusted depending on the indication. The new PFS syringes will be available in the coming months and the 6mg vials will continue to be available. For prescribing information, see here.
Zoryve Approved for Atopic Dermatitis
On July 9, 2024, Arcutis Biotherapeutics’ Zoryve® (roflumilast) Cream, 0.15%, was approved by the FDA for the treatment of mild to moderate atopic dermatitis in patients six years of age and older. Previously, a higher concentration (0.3%) of Zoryve Cream was approved to treat plaque psoriasis in patients six years of age and older. In addition, Zoryve Foam, O.3%, is approved to treat seborrheic dermatitis in patients who are at least nine years old. Zoryve is a topical phosphodiesterase-4 (PDE4) inhibitor that is applied once daily for all three uses. It can be used continuously as long as needed. Its newest indication, atopic dermatitis, is the most common form of eczema. It is a group of chronic skin diseases that involve inflammation and cause itchy, irritated bumps, crusts, and scales on the skin. According to the National Eczema Association, approximately 9.6 million children in the U.S. and 16.5 million adults in the U.S. have atopic dermatitis. Symptoms may improve and worsen unpredictably. Inflammation and scratching eventually can thicken and toughen the skin. Approval of Zoryve Cream, 0.15%, was based on clinical studies that showed it was effective in improving skin clearance and reducing itch compared to placebo. It was also well tolerated. Arcutis plans to launch Zoryve Cream, 0.15%, by the end of July. Full prescribing information can be found here.
Susvimo Reintroduced for Wet Age-Related Macular Degeneration
On July 8, 2024, Genentech announced the reintroduction of Susvimo® (ranibizumab) injection 100 mg/mL, an intravitreal therapy used via ocular implant for treating nAMD. It’s a tiny permanent reservoir that is implanted during a one-time outpatient procedure with enough drugs to last approximately six months. It can then be refilled every six months using a specifically designed needle. Susvimo was initially approved in 2021 but was voluntarily recalled a year later after testing did not meet the company’s standards. After updates and additional testing, the FDA approved its reintroduction. Susvimo contains ranibizumab, a VEGF inhibitor that is also found in the company’s Lucentis® and its biosimilars, Byooviz™ and Cimerli®. Susvimo will be available in the coming weeks. The prescribing information for Susvimo can be found here.
First Half of 2024 FDA Approvals Issues Document Available Through June 30, 2024, the FDA approved 27 novel pharmaceutical products for use in the United States. While 2023 was a record-breaking year with 72 novel approvals, this year is progressing almost as rapidly. Of the novel approvals year-to-date, 18 are specialty drugs. Also, 13 have an Orphan Drug Designation and 11 are Breakthrough Therapies. This document gives a brief overview of the FDA’s approval activity in the first six months of 2024 and offers a glimpse of potential new approvals through the end of the year.