Pegfilgrastim ANF(Prolong Pharmaceuticals)(Pegfilgrastim ANF(Prolong Pharmaceuticals))

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

ANF-Rho、PEG G CSF ANF、PEG-G-CSF-ANF

+ [2]

靶点

CSF-3R

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

肿瘤血液及淋巴系统疾病皮肤和肌肉骨骼疾病

在研适应症-

非在研适应症

乳腺癌化疗引起的发热性中性粒细胞减少症严重慢性中性粒细胞减少症

原研机构

Prolong Pharmaceuticals LLC

在研机构-

非在研机构

Prolong Pharmaceuticals LLC

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 4190

当前序列信息引自: *****

关联

4

项与 Pegfilgrastim ANF(Prolong Pharmaceuticals) 相关的临床试验

EUCTR2016-004539-18-FR / Unknown status临床2期

A Phase 2, Open-Label, Multicenter, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of ANF–Rho™ in Patients with Chronic Neutropenia

开始日期2018-08-27

申办/合作机构

Prolong Pharmaceuticals LLC

NCT03559387 / Terminated临床2期

A Randomized and Open-label Dose-finding, Ph. 2, Efficacy, Safety, and Pharmacokinetic Study of Once-per-cycle Prophylactic Injections of ANF-RHO™ Versus Pegfilgrastim (Neulasta®) in Non-metastatic Breast Cancer Patients at High-risk of Chemotherapy-induced Neutropenia

Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia

开始日期2017-08-03

申办/合作机构

Prolong Pharmaceuticals LLC

NL-OMON47295 / Completed临床2期

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN) - PGFN-001

开始日期2017-08-03

申办/合作机构

Prolong Pharmaceuticals LLC

100 项与 Pegfilgrastim ANF(Prolong Pharmaceuticals) 相关的临床结果

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100 项与 Pegfilgrastim ANF(Prolong Pharmaceuticals) 相关的转化医学

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100 项与 Pegfilgrastim ANF(Prolong Pharmaceuticals) 相关的专利（医药）

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19

项与 Pegfilgrastim ANF(Prolong Pharmaceuticals) 相关的文献（医药）

2023-09-01·Journal of Biophotonics

Ex vivo fluorescence imaging for the identification of rhodamine‐labeled bovine serum albumin and chitosan‐coated gold and silver nanoparticles

Article

作者: Madduri, Ramanadham ; Sana, Siva Sankar ; Venkatesan, Raja ; Eldesoky, Gaber E ; Devanabanda, Mallaiah ; Vadde, Ramakrishna ; Kim, Seong-Cheol

AbstractTherapeutic potential and toxic effects of in vivo administered gold nanoparticles (GNPs) and silver nanoparticles (SNP) depend on distribution in tissues. Rhodamine (Rho) labeled bovine serum albumin (BSA) and chitosan (Chi) were prepared by covalent conjugation and were characterized by fluorescence spectral analysis. GNP and SNP were coated with the labeled conjugates of BSA and chitosan by adsorption. The soluble Rho‐BSA or Rho‐Chi conjugates, uncoated, and conjugate‐coated GNP, and SNP were orally administered into 8‐week‐old rats. After 24 h, rats were euthanized and the liver, kidney, spleen, and thymus were dissected. The tissues were examined ex vivo using a small animal in vivo imaging system. The liver, kidney, and thymus displayed higher fluorescence due to increased accumulation of Rho‐BSA or Rho‐Chi conjugate‐coated nanoparticles (NPs) in the tissues as compared to the spleen where lower fluorescence was noticed. Tissues obtained from rats that were administered Rho‐BSA or Rho‐Chi conjugate‐coated GNP and SNP showed tenfold higher fluorescence intensity as compared to tissues from rats that were given soluble conjugates or NP alone. The results strongly suggest significant tissue distribution of NP following oral administration.

2023-02-01·Journal of Managed Care & Specialty Pharmacy

Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study

Article

作者: Vouri, Scott M ; Wang, Ching-Yu ; Brown, Joshua D ; Park, Haesuk ; Heldermon, Coy D

BACKGROUND: Real-world evidence on the comparative effectiveness of pegfilgrastim biosimilars compared with the originator product is limited. OBJECTIVE: To compare the risk of febrile neutropenia (FN) among users of pegfilgrastim biosimilars (pegfilgrastim-jmdb and pegfilgrastim-cbqv) and the originator product. METHODS: A retrospective cohort study was conducted using 2019 IBM MarketScan databases to assess comparative effectiveness of pegfilgrastim originator and biosimilars for prevention of FN among patients receiving myelosuppressive chemotherapy. Patients with cancer, including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas, initiating myelosuppressive chemotherapy courses were selected. We further selected patients who used pegfilgrastim originator and biosimilars within 3 days of chemotherapy completion. FN-associated hospitalizations were measured by International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes. After 1:1 propensity score matching, we used equivalence (with a margin of 6%) hypothesis tests to compare FN-related hospitalization risk in the first cycle and across all cycles between biosimilars and originator users. RESULTS: A total of 2,045 patients were included, of which 445 (21.8%) used pegfilgrastim-jmdb, 636 (31.1%) used pegfilgrastim-cbqv, and 964 (47.1%) used pegfilgrastim originator. After matching, 13 out of 445 originator users and 17 out of 445 pegfilgrastim-jmdb users developed FN after the first chemotherapy cycle (risk difference was 0.9%; P < 0.001 for equivalence test indicating statistical equivalence). After matching, 14 out of 633 originator users and 16 out of 633 pegfilgrastim-cbqv users developed FN (risk difference was 0.32%; P < 0.001 for equivalence test indicating statistical equivalence). Results across all cycles (including the first cycle) were consistent with that in the first cycle. CONCLUSIONS: In this real-world study of patients with cancer receiving myelosuppressive chemotherapy, there was no difference in FN risk between patients receiving pegfilgrastim originator and biosimilars in the first cycle and across all cycles. These results add further to the current evidence on pegfilgrastim biosimilars and support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients. Future studies assessing the tolerability, side effects, and other safety issues of pegfilgrastim biosimilars are needed.

2022-07-01·Journal of Managed Care & Specialty Pharmacy

Patient out-of-pocket and payer costs for pegfilgrastim originator vs biosimilars as primary prophylaxis of febrile neutropenia in the first cycle among a commercially insured population

Article

作者: Vouri, Scott M ; Wang, Ching-Yu ; Brown, Joshua D ; Park, Haesuk ; Heldermon, Coy D

BACKGROUND: It is unknown whether using pegfilgrastim biosimilars is cost saving in a real-world setting. OBJECTIVE: To compare medical costs including pegfilgrastim drug costs and febrile neutropenia (FN) treatment and management costs between pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-cbqv) and originator users for primary prophylaxis of febrile neutropenia. METHODS: A retrospective cohort study using 2019 IBM MarketScan Commercial and Medicare Supplemental databases was conducted in adult patients with cancer initiating myelosuppressive chemotherapy courses. At least 2 diagnoses of the same cancer (at least 7 days apart) were required within 30 days of the chemotherapy initiation date. Pegfilgrastim (excluding on-body injector) costs included drug costs only (excluding administration fees). FN-related costs included all FN-related health care utilizations that were defined as having neutropenia, fever, or infection diagnosis. Per-patient per-cycle (PPPC) out-of-pocket (OOP) costs, health plan costs, and total costs were compared between originator (excluding on-body injector) and biosimilars users in the first cycle. A generalized linear model and a 2-part model were used. RESULTS: A total of 1,930 patients were included, of whom 884 (45.8%) used pegfilgrastim originator, 427 (22.1%) used pegfilgrastim-jmdb, and 619 (32.1%) used pegfilgrastim-cbqv. Adjusted PPPC OOP pegfilgrastim costs in the first cycle were significantly lower for the biosimilars vs the originator ($182 for pegfilgrastim-jmdb and $159 for pegfilgrastim-cbqv vs $299 for originator, P < 0.0001 for both comparisons). However, there was no difference in health plan costs ($5,783 for pegfilgrastim-jmdb and $5,845 for pegfilgrastim-cbqv vs $5,618 for originator) and total costs. In addition, no difference was observed for adjusted PPPC FN treatment and management OOP costs, health plan costs, and total costs in the first cycle. FN treatment OOP costs were $192 for originator, $197 for pegfilgrastim-jmdb (P = 0.958), and $240 for pegfilgrastim-cbqv (P = 0.680). FN treatment health plan costs were $2,804 for originator, $2,970 for pegfilgrastim-jmdb (P = 0.692), and $2,745 for pegfilgrastim-cbqv (P = 0.879). CONCLUSIONS: In a commercially insured population, using pegfilgrastim biosimilars in the first cycle for primary prophylaxis of FN led to cost savings for patients but not payers. No difference in FN-related costs was observed.

100 项与 Pegfilgrastim ANF(Prolong Pharmaceuticals) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床2期	荷兰	Prolong Pharmaceuticals LLC	2017-08-03
乳腺癌	临床2期	法国	Prolong Pharmaceuticals LLC	2017-08-03
化疗引起的发热性中性粒细胞减少症	临床2期	法国	Prolong Pharmaceuticals LLC	2017-08-03
化疗引起的发热性中性粒细胞减少症	临床2期	荷兰	Prolong Pharmaceuticals LLC	2017-08-03
严重慢性中性粒细胞减少症	临床2期	-	Prolong Pharmaceuticals LLC	2015-10-01