Spherix Global Insights

Today, AbbVie announced the submission of regulatory applications to the FDA and European Medicines Agency for upadacitinib (Rinvoq®) for the treatment of adults with giant cell arteritis (GCA).    The submissions are supported by results from the SELECT-GCA Phase 3 study consisting of two periods designed to evaluate the safety and efficacy of upadacitinib in patients with GCA.   Read More: https://lnkd.in/eH9GGc2X.   #Rheumatology #GCA #Rinvoq #AbbVie

Kiniksa Pharmaceuticals has initiated enrollment for a Phase 2b clinical trial of abiprubart in Sjögren’s Disease, an autoimmune disorder lacking FDA-approved therapies. Abiprubart, a humanized anti-CD40 monoclonal antibody, aims to inhibit the CD40-CD154 interaction. The trial will assess treatment response with biweekly and monthly subcutaneous administration compared to placebo over 24 weeks, followed by a 24-week extension phase.   Kiniksa emphasizes the potential of abiprubart's convenient administration and expects continued financial stability amidst clinical development.   Read more: www. https://lnkd.in/eVU4_AHb   #Rheumatology #Abiprubart #SjögrensDisease

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has announced the FDA approval for ZORYVE (roflumilast) cream, 0.15%, a steroid-free treatment for mild to moderate atopic dermatitis (AD) in adults and children, ages 6 years and older. Clinical trials demonstrated its efficacy, safety, and tolerability over 56 weeks of treatment, with significant improvements seen in 90% of patients within 4 weeks and a notable reduction in itch within 24 hours of application. This marks the third FDA approval for Arcutis Biotherapeutics in two years, with commercial availability expected by the end of July. Read more: www. https://lnkd.in/e9yPngnY #Dermatology #AtopicDermatitis #ZORYVE

Happy Independence Day from Spherix! Today, we celebrate the freedom that shapes our nation. We wish you a safe and joyful 4th of July! #4thofjuly #independenceday #happyfourth

Eli Lilly and Company received FDA approval for Kisunla (donanemab-azbt) for the treatment of adults with early symptomatic Alzheimer's Disease (AD), including mild cognitive impairment and the mild dementia stage of AD. Kisunla, the first and only plaque-targeting therapy using a limited-duration treatment regimen based on amyloid plaque removal, is a once-monthly injection for IV infusion.    The approval is based on data from the TRAILBLAZER-ALZ 2 Phase 3 study where Kisunla showed a statistically significant response, with participants seeing up to a 39% lower risk of disease progression compared to placebo.    Read more: https://lnkd.in/eF_VjJvy   #Alzheimerdisease #EliLilly #Kisunla #donanemab #neurology

Formycon AG and Klinge Pharma GmbH have announced FDA approval of FYB203/AHZANTIVE® (aflibercept-mrbb), a biosimilar to Eylea®. FYB203/AHZANTIVE® targets Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal conditions by inhibiting Vascular Endothelial Growth Factor (VEGF). The approval was based on a comprehensive data package demonstrating comparable efficacy, safety, pharmacokinetics, and immunogenicity to Eylea®. Formycon AG has also submitted a marketing authorization application for FYB203 to the EMA, expecting a decision by early 2025. Read more: https://lnkd.in/e6Ps5XWw   #nAMD #Ophthalmology #FormyconAG #EMA #KlingeBiopharma

Apellis Pharmaceuticals, Inc. announced its setback with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) due to their negative opinion on Apellis' marketing authorization application (MAA) for intravitreal pegcetacoplan, intended for treating geographic atrophy (GA).  The decision follows a review emphasizing GA lesion size as a primary trial outcome and microperimetry as a functional measure. Despite multiple dissenting votes within the CHMP, Apellis plans to pursue re-examination, expecting a final decision by the fourth quarter of 2024. Read more: https://lnkd.in/etWNnyXQ   #ApellisPharmaceuticals #GeographicAtrophy #AgeRelatedMacularDegeneration #Ophthalmology #GA

Roche announced that the European Commission has approved OCREVUS subcutaneous (SC), the first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis (RMS/PPMS). Roche's OCREVUS SC is a 10-minute injection that follows the same administration schedule as the previously approved intravenous (IV) infusion. The European Commission's approval is based on the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood, when administered subcutaneously, and a safety and efficacy profile comparable to the IV formulation in patients with RMS and PPMS. More than 92% of patients reported being satisfied or very satisfied with the SC administration of OCREVUS. Read more: https://lnkd.in/ev9iM9Hk. #MS #Neurology #multiplesclerosis #RMS #PPMS

argenx announced the FDA approval of VYVGART Hytrulo for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients, becoming the first and only neonatal Fc receptor (FcRn) blocker approved in CIDP. VYVGART Hytrulo is a once weekly 30-to-90 second subcutaneous injection treatment.  The FDA approval is based on the 2023 ADHERE Study, the largest clinical trial of CIDP patients to date. In the study, 69% of patients treated with VYVGART Hytrulo demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint demonstrating a 61% reduction in the risk of relapse versus placebo. Read more: https://lnkd.in/e4iimU2s   #Neurology #CIDP #gMG #VYVGARTHytrulo

4D Molecular Therapeutics announced the clearance of the Investigational New Drug Application (IND) from the FDA for 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of geographic atrophy (GA).    The Phase 1 GAZE clinical trial for 4D-175 will assess patients with GA secondary to age-related macular degeneration (AMD) and is expected to begin H2 2024.   Read more: https://lnkd.in/eVbzWvMq   #4DMolecularTherapeutics #GeographicAtrophy #AgeRelatedMacularDegeneration #Ophthalmology