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Hemic and Lymphatic Diseases

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Disease Domain	Count

Hemic and Lymphatic Diseases	1
Neoplasms	1

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Interferons	1

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IFNAR(Interferon alpha/beta receptor)	1

Author: Qin, Albert ; Shao, Zonghong ; Bai, Jie ; Sato, Toshiaki ; Jin, Jie ; Chen, Suning ; Wu, Daoxiang ; Urbanski, Raymond ; Zhang, Xuhan ; Li, Yaning ; Zagrijtschuk, Oleh ; Duan, Minghui ; Du, Xin ; Zhang, Lei ; Wang, Li ; Li, Pei ; Zuo, Xuelan ; Zhou, Hu ; Xu, Na ; Zhang, Sujiang ; Shen, Weihong ; Xiao, Zhijian ; Zhang, Jingjing ; Wang, Wei

Ropeginterferon alfa-2b represents a new-generation pegylated interferon-based therapy and is administered every 2-4 weeks. It is approved for polycythemia vera (PV) treatment in the United States and Europe with a starting dose of 100 µg (50 µg for patients receiving hydoxyurea) and intra-patient dose titrations up to 500 µg at 50 µg increments, which took approximately 20 or more weeks to reach a plateau dose level. This study aimed to assess ropeginterferon alfa-2b at an alternative dosing regimen with a higher starting dose and quicker intra-patient dose titrations, i.e., the 250-350-500 μg schema, in 49 Chinese patients with PV with resistance or intolerance to hydroxyurea. The primary endpoint of the complete hematologic response rate at treatment weak 24 was 61.2%, which was notably higher than 43.1% at 12 months with the approved dosing schema. The JAK2^V617F allele burden decreased from baseline to week 24 (17.8% ± 18.0%), with one patient achieving a complete molecular response. Ropeginterferon alfa-2b was well-tolerated and most adverse events (AEs) were mild or moderate. Common AEs included alanine aminotransferase and aspartate aminotransferase increases mostly at grade 1 or 2 levels. Patients did not present with jaundice or significant bilirubin level increase. No grade 4 or 5 AEs occurred. Seven patients (14.3%) experienced reversible, drug-related grade 3 AEs. No AEs led to treatment discontinuation. Ropeginterferon alfa-2b at the 250-350-500 μg regimen is highly effective and well-tolerated and can help patients achieve greater and rapid complete hematologic and molecular responses.Clinical Trial Registration: This trial is registered at ClinicalTrials.gov (Identifier: NCT05485948) and in China (China National Medical Products Administration Registration Number: CTR20211664).

01 Jan 2021·[Rinsho ketsueki] The Japanese journal of clinical hematology

[The effect of ferric citrate hydrate as an iron replacement therapy in Japanese patients with iron deficiency anemia].

Article

Author: Mitsui, Hironori ; Nemoto, Takanori ; Arita, Kojo ; Hanaki, Koji ; Akizawa, Tadao ; Komatsu, Norio

Patients with iron deficiency anemia (IDA) need to take oral iron preparations, which serve as the first-line treatment in IDA, for several months in order to replenish body iron stores after the improvement of anemia. However, existing oral iron preparations have concerns regarding its long-term use due to side effects, such as gastrointestinal symptoms. Previous clinical studies have shown that ferric citrate hydrate (FC) exhibits sufficient therapeutic efficacy in patients with IDA and lowers the risks of nausea and vomiting in comparison with existing oral iron preparations. In this study, we evaluated the efficacy and safety of FC administration at doses of 500 and 1,000 mg/day for up to 24 weeks as iron replacement therapy in patients with IDA. The results of this study showed that both the doses of FC improved anemia and iron-deficiency conditions and led to sufficient iron replacement response in most patients with IDA. No safety concerns were identified. Therefore, FC is expected to be a novel oral iron preparation for patients with IDA.

100 Deals associated with PharmaEssentia Japan KK

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100 Translational Medicine associated with PharmaEssentia Japan KK

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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