Full Approval for Nuvaxovid in High-Risk Populations
On May 16, 2025, the US Food and Drug Administration (FDA) granted Novavax’s Nuvavoxid™ [coronavirus disease 2019 (COVID-19) vaccine, adjuvanted] full approval for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 years through 64 years of age who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g., asthma, cancer, diabetes, obesity, smoking). This is the only recombinant, protein-based, non-mRNA COVID-19 vaccine available and has been available under Emergency Use Authorization since July 2022. Unlike the mRNA-based vaccines from Pfizer/BioNTech and Moderna, Novavax uses a more traditional method of incubating the proteins for its vaccine in insect cells. An adjuvant derived from a natural source is added to increase immune response. The full approval came after the planned April 1, 2025, FDA Action (PDUFA) date and is based on a phase III trial evaluating use as a two-dose series initially and as a single booster dose, which showed the vaccine to be safe and effective. The FDA has asked for a phase four, placebo-controlled efficacy and safety study in people ages 50 years to 64 years without high-risk conditions for severe COVID-19 before granting approval in this population. Typically, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommends the populations recommended for vaccination, not the FDA. However, the committee is expected to align and recommend this risk-based approval over universal booster recommendations in the May 22, 2025, meeting. The FDA is also requiring additional trials on myocarditis, inflammation of the heart, and pericarditis, thin tissues surrounding the heart, post-vaccination. The recommended dose is two intramuscular (IM) injections with the second three weeks after the first. Novavax expects to launch Nuvavoxid this fall in time for the 2025-2026 season. Full prescribing information is here.
Indication Expansion for Jivi
Bayer announced that Jivi® [antihemophilic factor (recombinant), PEGylated-aucl], a recombinant DNA-derived, extended half-life Factor VIII concentrate, was approved for use in pediatric patients seven years of age and older with hemophilia A (congenital Factor VIII deficiency) on May 19, 2025. Initially approved in 2018 for use in patients 12 years of age and older, Jivi is used for on-demand treatment and control of bleeding episodes, perioperative management of bleeding episodes and routine prophylaxis to reduce the frequency of bleeding episodes. The recommended initial dose for children ages seven years to 12 years of age is 60IU/kg twice weekly, adjusting the dose based on clinical response and recovery, while the dose for adults and adolescents is 30-40IU/kg twice weekly with the ability to dose every five days at 45-60IU/kg. Updated prescribing information is here.
FDA Drug Safety Communication for Oral Allergy Medications
On May 16, 2025, the FDA issued a drug safety communication warning that patients stopping cetirizine (e.g., Zyrtec) and levocetirizine (e.g., Xyzal) after long-term use may experience severe itching. Cetirizine and levocetirizine are available as both prescription and over the counter (OTC) medications to treat allergies and chronic hives by blocking histamine that the body releases during allergic reactions. The itching, also called pruritus, has been reported in 197 Americans who stopped using these medicines daily, typically for at least a few months to years who did not have itching prior to taking the medications. The cases were rare compared to how often these medications are used. Restarting the antihistamine resolved pruritus in most individuals, and tapering off the medications resolved symptoms in some. The prescription information for cetirizine and levocetirizine now includes a new warning about potential risks and it requests this warning to be added to the Drug Facts Label of OTC formulations. Click here for more information.
FDA Releases New Regulatory Framework for COVID Vaccination Approvals
The FDA announced a plan for new approval standards for the annual COVID-19 boosters for healthy Americans under 65 years of age on May 20, 2025. Published in the New England Journal of Medicine by FDA commissioner Marty Makary and top US vaccine Regulator Vinny Prasad, this guidance explains that immunogenicity data, or proof that vaccination causes production of antibodies, may continue to be used for approval of COVID vaccines foradults over 65 years or people at least six months of age who have health issues that put them at high risk for severe COVID-19. However, approval for use in healthy children and adults the FDA will now require randomized, placebo-controlled data evaluating clinical outcomes. The full paper is available here.
Diabetic Retinopathy Indication for Susvimo
On May 22, 2025, the FDA approved Genentech’s Susvimo® (ranibizumab) 100mg/mL injection for the treatment of diabetic retinopathy in those who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication. Also approved to treat neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), it is a tiny permanent reservoir that is implanted surgically into the eye and filled with 100mg of medication – enough to last approximately nine months. The implanted port delivery system (PDS) can be refilled indefinitely. Containing the same medication as in Lucentis®, Susvimo is a VEGF inhibitor that works by blocking the formation of new blood vessels in the back of the eye. It is not interchangeable with Lucentis, which is injected once a month, or any other ranibizumab. Approval is based on the achievement of superior improvements on the Diabetic Retinopathy Severity Scale at one-year for those who received Susvimo every nine months compared to those who only received monthly clinical observation in the phase III study. No individuals in the Susvimo group required additional treatment within one year. The recommended dose is 2mg continuously delivered via the implant with refills every 36 weeks. Here is the updated prescribing information.
Zoryve Foam Approved for Psoriasis
Arcutis Biotherapeutics announced that the FDA approved Zoryve® (roflumilast) topical foam 0.3% on May 22, 2025, for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. The foam formulation was initially approved in 2023 for seborrheic dermatitis in patients nine years of age and older, while the 0.15% cream formulation treats mild to moderate atopic dermatitis and plaque psoriasis in those six years of age and older. A topical phosphodiesterase-4 (PDE4) inhibitor, its foam formulation makes it gentler on the skin and easier to use on hairy areas than creams or ointments. Approval was based on a phase III trial showing 66.4% of patients treated with Zoryve achieved Scalp-Investigator Global Assessment success compared to 27.8% treated with a matching vehicle (p<0.0001) and 45.5% achieved Body-Investigator Global Assessment success compared to 20.1% in the vehicle group (p<0.00001). The trial also showed 65.3% of those treated with Zoryve achieved a significant improvement in scalp itch compared to 30.3% in the vehicle group (p<0.0001). Zoryve is rubbed into affected areas of skin once a day, avoiding contact with the eyes, mouth and vagina. It can be used continuously as long as needed. The updated prescribing information is here.
Nucala Approved for COPD
On May 22, 2025, the FDA granted Nucala® (mepolizumab – GSK) a new indication as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Eosinophilic phenotype is determined by a blood test that measures the levels of eosinophils, a white blood cell that indicates risk of exacerbation, and Nucala was evaluated in those with blood eosinophil count (BEC) ≥150 cells/µL. According to GSK, over one million Americans may be eligible for treatment with Nucala as 70% of COPD patients are inadequately controlled on inhaled triple therapy and continue to exacerbate with a BEC at 150cells/ µL and higher. Nucala blocks the action of interleukin-5 (IL-5) to decrease eosinophils, white blood cells that contribute to increased sensitivity of the airways. When added to triple inhaled therapy, Nucala showed a statistically significant 21% reduction in the annualized rate of moderate or severe exacerbations compared to the placebo. The recommended dose for treating COPD is 100mg administered as a subcutaneous (SC) injection every four weeks. Nucala also has indications for treating severe asthma with an eosinophilic phenotype, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). Revised prescribing information is here.