In a significant stride for chronic disease management, FDA granted approvals for Roche’s lupus nephritis treatment and Novo Nordisk’s cardiovascular-risk-reducing oral semaglutide for adults with type 2 diabetes, underscoring the agency’s continued momentum in advancing treatments for complex, high-burden conditions.

Novo Nordisk

Novo Nordisk recently announced FDA’s approval of Rybelsus (which is the only oral GLP-1 medication currently available) for reducing the risk of major adverse cardiovascular events (MACE), including cardiovascular death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior cardiovascular event or not.¹ SOUL trial results help reinforce the clinical profile of the semaglutide molecule, with the overall safety profile of the oral semaglutide 14 mg in SOUL trail, staying consistent with previous trail results.¹

"As the only FDA-approved GLP-1 therapy in a pill, now recognized for its proven cardiovascular benefits, a new benchmark has been set for future oral innovations," said Dave Moore, executive vice president, US operations of Novo Nordisk Inc. "The semaglutide molecule has consistently demonstrated robust outcomes across multiple, large-scale trials, further reinforcing the already established cardiovascular profile it delivers for patients."

With its recent approval, the new indication makes Rybelsus the only oral GLP-1 medicine approved to reduce the risk of MACE in adults diagnosed with type 2 diabetes who are at high risk for these events.¹ Rybelsus serves for both primary prevention, reducing the risk of major adverse cardiovascular events by preventing or managing risk factors in adults who are at high risk for these events, and secondary prevention, reducing the risk of another event in people who have had a serious CV event.¹

Roche

Roche announced that FDA has approved Gazyva/Gazyvaro (obinutuzumab) for adult patients with active lupus nephritis (LN), who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients.² After patients receive four initial doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, which offers patients an effective and potentially more convenient treatment option compared to traditional targeted therapies. This approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies, as results from the REGENCY study shows that almost half of the participants (46.4%) on Gazyva/Gazyvaro in combination with standard therapy achieved a complete renal response compared to 33.1% on standard therapy alone.² The results were also met with clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria, all signaling improved disease control. Additionally, Gazyva/Gazyvaro’s safety profile remained consistent with its profile observed in its haematology-oncology indications.²

“As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health,” said Louise Vetter, president and chief executive officer of the Lupus Foundation of America. “The FDA’s approval of Gazyva/Gazyvaro offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”

Sources

1. FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event Novo Nordisk October 17, 2025 https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-oral-semaglutide-for-cardiovascular-cv-risk-reduction-in-adults-with-type-2-diabetes-who-are-at-high-risk-including-those-who-have-not-had-a-prior-cv-event-302588005.html
2. FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis Roche October 20, 2025 https://www.globenewswire.com/news-release/2025/10/20/3169060/0/en/FDA-approves-Roche-s-Gazyva-Gazyvaro-for-the-treatment-of-lupus-nephritis.html