International Top Pharmaceutical Companies Weekly News — May 13, 2024 to May 19, 2024

【Answer 1】 • UCB: On May 14, 2024, UCB announced that *Neurology* published post-hoc analysis data from the pivotal Phase 3 RAISE trial and the ongoing Phase 3 RAISE-XT open-label extension (OLE) study, evaluating the long-term impact of zilucoplan on fatigue in adult patients with mild-to-severe anti-acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis (gMG). The results showed that gMG patients treated with once-daily subcutaneous complement C5 inhibitor zilucoplan experienced clinically meaningful improvements in fatigue sustained for over one year versus baseline; a clinically meaningful improvement was defined as a change of −3.5. The post-hoc analysis revealed that, from double-blind baseline to Week 12, the zilucoplan group (n=86) demonstrated improvement in mean Neuro-QoL Short Form Fatigue T-scores, with a clinically meaningful difference versus the placebo group (n=88); least-squares mean difference: −3.61 [nominal p-value = 0.0060]. These improvements were sustained through Week 60 (mean [SE] CFB −9.15 [1.80]). At Week 12, a significantly higher proportion of patients receiving zilucoplan (n=34, 47.2%) versus placebo (n=23, 28.4%; p = 0.017) achieved improvement of ≥1 point in fatigue severity score versus baseline. Fatigue improvements observed during the RAISE double-blind period persisted into the ongoing OLE study RAISE-XT and were maintained through Week 60 (mean [SE] CFB −10.71 [1.81]), indicating that zilucoplan can improve fatigue in MG patients for up to 60 weeks. In patients transitioning from placebo to zilucoplan in the OLE (placebo-switch cohort), improvements were observed within the first week after switching to zilucoplan 0.3 mg/kg (Week 13). Regarding fatigue severity scores, at double-blind baseline, the majority of patients reported 'severe' or 'moderate' fatigue (n=66, 78.6%; N = 84). By Week 60, most patients had improved to 'mild' or 'no' fatigue (n=55, 65.5%). These findings were consistent across both the zilucoplan group and the placebo-switch group (data not shown). Overall, zilucoplan was well tolerated with a favorable long-term safety profile. Among the 200 enrolled patients, treatment-emergent adverse events (TEAEs) occurred in 188 (94.0%), and serious TEAEs occurred in 64 (32.0%). The most common TEAEs were myasthenia gravis (worsening) (26.0%), COVID-19 (24.5%), headache (17.5%), diarrhea (15.0%), and nasopharyngitis (15.0%). Seventeen patients (8.5%) discontinued treatment permanently due to TEAEs. gMG is a rare, chronic, heterogeneous, and unpredictable autoimmune disease characterized by dysfunction and damage at the neuromuscular junction (NMJ).

[June 21] What did scientists discover this week?

【Answer 2】 Regarding hypoglycemic events, the incidence rates were similar between the insulin icodec group and the U100 group: observed rates of Level 2 (<54 mg/dL) and Level 3 (severe) hypoglycemia were 52.5 and 45.6 events per 100 patient-years, respectively. No new safety concerns related to insulin icodec were identified in the study. The proportion of patients experiencing adverse events was comparable between the insulin icodec and U100 groups. Insulin icodec is an investigational long-acting basal insulin analog with a half-life of up to 196 hours. After injection, insulin icodec binds tightly but reversibly to albumin, resulting in sustained, gradual, and stable glucose-lowering effects over one week. The newly released data address a key question raised by many when Novo Nordisk first proposed the concept of weekly insulin: whether reducing dosing frequency would increase the risk of hypoglycemia. Novo Nordisk plans to initiate Phase III clinical development of insulin icodec later this year, focusing on insulin-naïve patient populations, while also assessing patient acceptance of and adherence to this lower-frequency dosing insulin product. If approved, insulin icodec—a long-acting basal insulin analog administered only once weekly—would offer a novel treatment option for patients with type 2 diabetes, reducing basal insulin injections to just once per week. Wednesday, June 17 New rapid-acting insulin! Eli Lilly’s Lyumjev (rapid-acting insulin lispro) approved by the U.S. FDA for effective postprandial glucose control! Eli Lilly recently announced that the U.S. Food and Drug Administration (FDA) has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), a new rapid-acting prandial insulin product indicated to improve glycemic control in adult patients with type 1 and type 2 diabetes. Lyumjev is a novel, rapid-acting formulation of insulin lispro designed to accelerate insulin absorption into the bloodstream and lower blood glucose levels. As a rapid-acting prandial insulin, Lyumjev controls postprandial hyperglycemia in adult diabetic patients in a manner analogous to the natural insulin response in individuals without diabetes. Previously, Lyumjev received approvals from multiple global regulatory authorities, including Japan and the European Union in March 2020. Eli Lilly is now working to make Lyumjev available to people with diabetes in the United States as soon as possible. This approval was based on data from the Phase III PRONTO-T1D and PRONTO-T2D trials. These two randomized, active-controlled, treat-to-target studies were conducted separately in adult patients with type 1 and type 2 diabetes, comparing Lyumjev with Humalog (insulin lispro, 100 units/mL).

US FDA approves Lilly's once-weekly insulin injection for type 2 diabetes

Sep 24, 2026

The US FDA approved Eli Lilly's once-weekly basal insulin Onswik for type 2 diabetes, potentially reducing annual injections by over 300 compared to daily alternatives. Approval followed late-stage trials involving over 3,400 adults showing efficacy comparable to existing treatments.

reuters

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