MedPath

Insulin icodec

Generic Name
Insulin icodec
Brand Names
Awiqli
Drug Type
Biotech
CAS Number
1188379-43-2
Unique Ingredient Identifier
P7YU3ED05N

Novel Therapies to Watch in 2025: Oncology, Hematology, and Neurology

• Tarlatamab (Imdelltra) is set to transform small cell lung cancer treatment, targeting DLL3-expressing cells and potentially becoming the standard of care for previously treated ES-SCLC. • Fitusiran, an antithrombin-targeting siRNA, offers a novel approach to hemophilia A or B treatment, demonstrating significant reductions in annualized bleeding rates in phase 3 trials. • Vepdegestrant (ARV-471), a PROTAC protein degrader, shows promise in ER+/HER2- metastatic breast cancer, potentially offering a more effective protein degradation mechanism. • Cobenfy (xanomeline and trospium chloride) represents a new class of schizophrenia treatment, selectively targeting M1 and M4 receptors, with observed improvements in clinical trials.

Novartis and Apellis Advance C3G Therapies Towards FDA Submission

• Novartis' Fabhalta (iptacopan) demonstrated significant proteinuria reduction in the Phase III APPEAR-C3G trial, meeting its primary endpoint and supporting regulatory submissions. • Apellis' Empaveli (pegcetacoplan) showed a substantial reduction in proteinuria and C3c deposit clearance in the Phase III VALIANT trial, indicating early efficacy in C3G patients. • Nephrologists express a strong interest in new C3G therapies that can slow eGFR decline and reduce proteinuria, addressing the urgent need for innovative treatments. • Spherix data suggests treatment preferences may be influenced by administration route, with Fabhalta's oral administration potentially offering an advantage.

Biopharma Sector Shows Recovery: Bristol-Myers Squibb and Gilead Lead Market Gains

• The biopharmaceutical sector is showing signs of recovery, with a 2% rise in combined market capitalization among the top 20 global companies. • Bristol-Myers Squibb led the recovery with a 24.6% increase in market capitalization, driven by the FDA approval of Cobenfy for schizophrenia. • Gilead Sciences experienced a 22.1% rise, spurred by FDA approvals for Livdelzi in primary biliary cholangitis and Trodelvy in HR-/HER2- breast cancer. • Novo Nordisk and Eli Lilly faced setbacks, with Novo Nordisk seeing an 18.2% drop after the FDA rejected its weekly insulin icodec application.

Eli Lilly's Weekly Insulin Efsitora Shows Promise in Phase 3 Trials

• Eli Lilly's efsitora, a weekly insulin injection, demonstrated effectiveness comparable to daily insulin in Phase 3 trials for type 2 diabetes. • In the QWINT-1 trial, patients new to insulin saw similar A1C reductions with efsitora compared to daily insulin after 52 weeks. • The QWINT-3 trial showed efsitora also effectively lowered A1C levels in patients previously on daily insulin, with results after 26 weeks. • Efsitora offers the potential for 313 fewer injections per year, aiming to simplify insulin therapy and improve patient adherence.

Eli Lilly's Efsitora Alfa Shows Promise in Type 2 Diabetes Treatment

• Eli Lilly's efsitora alfa, a once-weekly insulin, demonstrated non-inferiority to daily insulin in Phase 3 trials for type 2 diabetes, meeting its primary endpoint. • The safety profile of efsitora alfa was consistent with daily insulin, suggesting it could be a viable option for patients seeking less frequent dosing. • Efsitora alfa aims to compete with Novo Nordisk's once-weekly insulin, Awiqli, in the growing market for diabetes treatments, addressing a significant patient population. • Despite competition, efsitora alfa represents a potential revenue stream for Eli Lilly, complementing its already strong portfolio and pipeline, including drugs like Verzenio and Mounjaro.
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