Data from Pharmawand - Curated by EPG Health - Date added 23 September 2018

Astellas Pharma Inc. has announced that roxadustat, an inhibitor of hypoxia ¬inducible factor (HIF) prolyl hydroxylase activity, met its primary endpoints in the Phase III ALPS study by demonstrating superiority in efficacy versus placebo in terms of both hemoglobin (Hb) response rate in the first 24 weeks and Hb change from baseline at Weeks 28 to 521. The preliminary safety analysis for this trial shows an overall event profile consistent with the results seen in previous roxadustat studies in CKD patients with anemia.

The ALPS study is the first of three Astellas Phase III studies conducted mainly in EMEA to report. The study forms part of a wider large-scale global Phase III development program for roxadustat conducted in collaboration with its partner FibroGen, Inc. and will ultimately support filing and reimbursement in Europe. The ALPS study is a randomized, double-blind, placebo-controlled study of the efficacy and safety of roxadustat for the treatment of anemia in CKD in patients not on dialysis.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Migraine Knowledge Centre

Migraine Knowledge Centre

The Migraine Knowledge Centre features latest research on the prevalence and impact of migraine, the proposed neurological basis of the condition (and how this is being translated into new and exciting drug therapies), as well as current patient care strategies collated from headache organisations worldwide.

Load more

Related Content