This approval is supported by results from the phase III ARCADIA and OLYMPIA clinical trials, where Nemluvio significantly reduced itch, improved skin lesions, and alleviated sleep disturbances in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis.
The ARCADIA 1 and ARCADIA 2 trials demonstrated that patients receiving Nemluvio, administered subcutaneously every four weeks alongside background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), achieved statistically significant improvements in skin clearance on both co-primary endpoints at Week 16 compared to the placebo +TCS/TCI group. The trials also met all key secondary endpoints, showing notable reductions in itch as early as Week 1 and significant improvements in sleep disturbance.
NEMLUVIO is approved by the FDA for treating atopic dermatitis and prurigo nodularis. It is currently under regulatory review for these conditions in multiple countries, including Canada, Brazil, and South Korea, as well as through the Access Consortium framework in Australia, Singapore, and Switzerland. Additional regulatory submissions are ongoing.
Galderma has previously stated that Nemluvio’s peak sales are projected to exceed $2 billion, beyond the 2023-2027 mid-term forecast. The company expects the drug to reach ‘blockbuster’ net sales status by the end of 2027.
GSK’s Penmenvy Wins FDA Nod
GSK plc announced that the FDA has approved Penmenvy, a meningococcal vaccine covering Groups A, B, C, W, and Y, for individuals aged 10 to 25 years. The vaccine targets five key serogroups of Neisseria meningitidis, which are common causes of invasive meningococcal disease (IMD).
Penmenvy combines antigenic components from GSK’s existing meningococcal vaccines—Bexsero (targeting Group B) and Menveo (covering Groups A, C, Y, and W-135). The approval was supported by positive data from two Phase III clinical trials [NCT04502693; NCT04707391], involving over 4,800 participants aged 10-25 years. These studies assessed the vaccine’s safety, tolerability, and immune response, confirming that its safety profile aligns with GSK’s licensed meningococcal vaccines.
Incorporating GSK’s MenABCWY vaccine into healthcare practices may streamline meningococcal vaccination and enhance protection for US adolescents against these five serogroups. While MenB is the primary cause of IMD in this age group, vaccination rates remain low—only about 13% receive the recommended two-dose series, and around 32% receive at least one dose. Notably, GSK manufactures three out of four MenB vaccine doses administered in the US, strengthening its position in the market, as MenB-containing vaccinations must be completed with the same manufacturer’s vaccine.
The CDC’s Advisory Committee on Immunization Practices (ACIP) is set to review and vote on recommendations for the use of GSK’s MenABCWY vaccine in adolescents and young adults during its meeting on February 26, 2025.
Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT
Ono Pharmaceutical Co., Ltd. announced that the FDA has approved ROMVIMZA (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgical removal could lead to worsened functional impairment or severe complications. The FDA had previously granted Fast Track designation and Priority Review for ROMVIMZA, which was developed by Deciphera Pharmaceuticals, Inc., a wholly owned subsidiary of Ono.
TGCT is a rare, non-cancerous tumor that develops in or around joints, caused by abnormal regulation of the CSF1 gene, leading to excessive CSF1 production. If untreated or recurrent, it can cause joint and tissue damage, potentially resulting in significant disability.
The total number of TGCTs prevalent cases in the United States was around 250K in 2023. According to DelveInsight estimates, there were around 198K prevalent cases of localized and 51K prevalent cases of diffuse TGCT in the United States in 2023. The prevalence is projected to increase during the forecasted period.
The FDA’s decision was based on efficacy and safety data from the pivotal Phase 3 MOTION study, which evaluated ROMVIMZA in TGCT patients not eligible for surgery and without prior anti-CSF1/CSF1R therapy (though previous treatment with imatinib or nilotinib was permitted). Additionally, results from a Phase I/II study supported the approval. In the MOTION trial, ROMVIMZA demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, assessed by blinded independent radiologic review (BIRR) using RECIST v1.1 criteria (40% in the ROMVIMZA group vs. 0% in the placebo group, p <0.0001).
The primary endpoint was further validated by notable improvements in active range of motion, patient-reported physical function, and pain reduction in the vimseltinib group compared to placebo at Week 25. The safety profile of ROMVIMZA was manageable and aligned with findings from the Phase I/II trial.
Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings
Bristol Myers Squibb announced that the Phase III RELATIVITY-098 trial, which evaluated OPDUALAG (nivolumab and relatlimab-rmbw) as an adjuvant treatment for patients with completely resected stage III-IV melanoma, did not meet its primary endpoint of recurrence-free survival (RFS). The safety profile of OPDUALAG observed in the trial was consistent with the known profiles of nivolumab and relatlimab.
“We are disappointed by the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not produce the same improved efficacy seen in advanced melanoma,” said Jeffrey Walch, M.D., Ph.D., vice president and global program lead for Opdualag at Bristol Myers Squibb. “Patients with completely resected tumors may lack sufficient antitumor T cells for Opdualag to have its full effect. However, Opdualag remains a standard treatment for first-line therapy in unresectable or metastatic melanoma, and we continue to explore its potential in other tumor types, including non-small cell lung cancer.”
For adjuvant melanoma, OPDIVO (nivolumab) continues to be the standard treatment for adults and pediatric patients aged 12 and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. Additionally, OPDIVO QVANTIG (nivolumab + hyaluronidase-nvhy) was recently approved in the U.S. as a subcutaneous option for the adjuvant treatment of adults with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment
Astellas Pharma Inc. has announced that the FDA has approved an expanded U.S. prescribing label for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy due to age-related macular degeneration (AMD). With this approval, IZERVAY can now be prescribed without restrictions on dosing duration, offering greater flexibility for physicians and patients in managing geographic atrophy.
This approval follows Astellas’ resubmission of the supplemental New Drug Application (sNDA) for IZERVAY on December 26, 2024, after discussions with the FDA to clarify feedback from the Complete Response Letter (CRL) issued in November 2024. The updated label was based on positive results from the GATHER2 Phase 3 clinical trial, which assessed the efficacy and safety of IZERVAY over two years.
Since receiving a permanent J-code in April 2024, IZERVAY has experienced continuous growth in the U.S., with over 210,000 vials distributed by the end of December 2024. Post-marketing safety data remains consistent with clinical trial results, showing no new or significant safety concerns, thus reinforcing confidence in IZERVAY’s safety profile.
The GATHER2 study showed that IZERVAY consistently reduced the rate of geographic atrophy lesion growth in patients with geographic atrophy caused by AMD over two years, compared to a sham treatment. The benefits of IZERVAY were noticeable as early as six months and progressively increased over time, more than doubling by the end of the second year compared to the first year.
In the GATHER2 trial, IZERVAY was generally well tolerated over two years. There was one case each of non-serious intraocular inflammation and culture-positive endophthalmitis, with no instances of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over the two years, there was a slight increase in the incidence of choroidal neovascularization with IZERVAY (11.6%) compared to sham (9%). IZERVAY received approval from the FDA on August 4, 2023, for the treatment of geographic atrophy secondary to AMD.
