Pavblu (aflibercept-ayyh) / Amgen - LARVOL DELTA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025 (European Medicines Agency) - "On 30 January 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pavblu, intended for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV)....Pavblu will be available as 40 mg/ml solution for injection in pre-filled syringe and vial."

CHMP • Ophthalmology • Wet Age-related Macular Degeneration

Drugs for age-related macular degeneration. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product. (PubMed, Ophthalmol Ther) - "This integrated assessment of results from the in vitro pharmacology assessment and in vivo PK and TK/toxicology profiles formed the nonclinical portion of the totality of evidence demonstrating ABP 938 is a biosimilar to aflibercept RP."

Journal • Ophthalmology • Retinal Disorders

FDA Approves Pavblu for Retinal Conditions (MJH Life Sciences) - "The FDA has approved Pavblu (aflibercept-ayyh), the fifth biosimilar referencing Eylea (aflibercept).1 The new product is approved for the treatment of retinal conditions, including neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy....The approval was based on data from a randomized, double-masked, phase 3 study (NCT04270747) assessing the safety and efficacy of Pavblu (ABP 938) compared with Eylea in patients with wet AMD."

FDA approval • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product. (PubMed, Ophthalmol Ther) - "ABP 938 was structurally and functionally similar to aflibercept RP. Since aflibercept RP sourced from the US and EU were analytically similar, this allows for the development of a scientific bridge such that a single-source RP can be used in nonclinical and clinical studies."

Journal • Ophthalmology

AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS (Amgen Press Release) - "The FDA accepted the Biologics License Application for ABP 938, an investigational biosimilar to EYLEA (aflibercept)."

BLA • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

AMGEN REPORTS FIRST QUARTER FINANCIAL RESULTS (PRNewswire) - "The final analysis from a Phase 3 study evaluating the efficacy and safety of ABP 938, an investigational biosimilar to EYLEA® (aflibercept) compared with EYLEA in patients with neovascular age-related macular degeneration, is expected in H1 2023."

P3 data • Age-related Macular Degeneration • Ophthalmology

A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) (clinicaltrials.gov) - P3 | N=49 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) (clinicaltrials.gov) - P3 | N=48 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) (clinicaltrials.gov) - P3 | N=48 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3 | N=579 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) (clinicaltrials.gov) - P3 | N=48 | Not yet recruiting | Sponsor: Amgen

New P3 trial

AMGEN REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS (PRNewswire) - "The primary analysis of a randomized, double-blind, active controlled, Phase 3 study evaluating the efficacy and safety of ABP 938, an investigational biosimilar to EYLEA® (aflibercept) compared with EYLEA met its primary endpoint in subjects with neovascular age-related macular degeneration; final analysis is expected in 2023."

P3 data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

AMGEN REPORTS FIRST QUARTER 2022 FINANCIAL RESULTS (PRNewswire) - "AMGEVITA™ (adalimumab) sales increased 2% year-over-year for the first quarter, driven by 16% volume growth, partially offset by foreign exchange impact and lower net selling price resulting from increased competition. AMGEVITA continues to be the most prescribed adalimumab biosimilar in Europe...Phase 3 studies of ABP 938, an investigational biosimilar to EYLEA® (aflibercept), and ABP 959, an investigational biosimilar to SOLIRIS® (eculizumab), are on track, with data expected in 2022."

Commercial • P3 data • Immunology • Inflammatory Bowel Disease

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3 | N=579 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Amgen Reports Third Quarter 2021 Financial Results (PRNewswire) - "Repatha sales increased 33% year-over-year for the third quarter, primarily driven by 42% volume growth partially offset by lower net selling price...A Phase 3 study of ABP 938, an investigational biosimilar to EYLEA® (aflibercept) continues to enroll patients, with data expected in 2022."

Commercial • Enrollment status • New P3 trial • P3 data • Heterozygous Familial Hypercholesterolemia • Homozygous Familial Hypercholesterolemia • Ophthalmology

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3; N=566; Recruiting; Sponsor: Amgen; Trial completion date: Jun 2022 ➔ Dec 2022

Clinical • Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3; N=566; Recruiting; Sponsor: Amgen; Trial primary completion date: Jan 2022 ➔ Jun 2022

Clinical • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3; N=566; Recruiting; Sponsor: Amgen; Trial completion date: Dec 2022 ➔ Aug 2022

Trial completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Novel Drug Delivery System for the Management of Wet AMD - Episode 3: Treat and Extend Approach to Anti-VEGF Therapy for AMD (HCPLive) - "Diana Do, MD: I agree, Carl. Clearly, intravitreal VEGF inhibitors, which are administered in the clinic, are the first-line treatment for wet age-related macular degeneration. There are 4 medicines available in clinical use. Three of these agents are FDA approved: ranibizumab, aflibercept, and brolucizumab. One agent, bevacizumab, is used off-label. Fortunately, there's a robust body of scientific evidence that suggests all these medicines are very efficacious when dosed appropriately for the treatment of wet macular degeneration."

Video

Amgen Reports First Quarter 2021 Financial Results (PRNewswire) - "Repatha sales increased 25% year-over-year for the first quarter to record quarterly sales of $286 million, driven by 36% volume growth, partially offset by lower net selling price and the effect of favorable changes to estimated sales deductions in the prior year. We continue to see strong sales growth internationally with 42% volume growth in ROW regions. In the U.S., total prescription (TRx) volumes grew 32% year-over-year...Phase 3 studies of ABP 654, a biosimilar candidate to STELARA® (ustekinumab), and ABP 938, a biosimilar candidate to EYLEA® (aflibercept), continue to enroll patients."

Enrollment status • Sales • Cardiovascular • Dyslipidemia • Heterozygous Familial Hypercholesterolemia • Homozygous Familial Hypercholesterolemia

Effectiveness and Safety of ABP 938 in Patients With Neovascular Age-related Macular Degeneration [Neovascular(Wet)AMD] (clinicaltrials.gov) - P3; N=566; Recruiting; Sponsor: Amgen; Trial completion date: Jul 2023 ➔ Dec 2022; Trial primary completion date: Sep 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3; N=566; Recruiting; Sponsor: Amgen; Trial completion date: Jul 2022 ➔ Jul 2023

Clinical • Trial completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3; N=566; Recruiting; Sponsor: Amgen; Not yet recruiting ➔ Recruiting; Trial completion date: Mar 2022 ➔ Jul 2022; Trial primary completion date: May 2021 ➔ Sep 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Gene Therapies • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (clinicaltrials.gov) - P3; N=566; Not yet recruiting; Sponsor: Amgen; Initiation date: Mar 2020 ➔ Jul 2020

Clinical • Trial initiation date