Roxadustat Effective in Chronic Kidney Disease Patients With Anemia

By December 26, 2018

The global Phase 3 program consists of more than 9,000 patients.

Ultomiris Approved for Paroxysmal Nocturnal Hemoglobinuria

By December 21, 2018

The safety and efficacy of Ultomiris in patients with PNH was assessed in 2 open-label, randomized, active-controlled, non-inferiority Phase 3 studies.

Smartphone App Uses Fingernail Bed Images to Detect Anemia

December 13, 2018

App uses color and metadata from fingernails to detect hemoglobin levels in the blood

Promacta Approved as First-Line Treatment for Severe Aplastic Anemia

By November 19, 2018

The approval was based on data from a single-arm, open-label sequential cohort study in which patients received Promacta in combination with horse antithymocyte globulin (h-ATG) and cyclosporine.

Biosimilar Retacrit, an Erythropoiesis-Stimulating Agent, Now Available

By November 14, 2018

Retacrit will be priced 57.1% below the Wholesale Acquisition Cost (WAC) of Procrit and 33.5% below the WAC of Epogen, at $11.03 per 1000 Units/mL.

FDA Approves New DNA-Based Test to Verify Blood Compatibility

October 15, 2018

If blood with poorly matched antibodies is transfused, the procedure is more likely to lead to red blood cell destruction and a transfusion reaction, the agency explained.

Hepcidin Mimetic Fast-Tracked for Beta-Thalassemia Treatment

By September 27, 2018

The Company is currently planning a Phase 2 trial of PTG-300 in beta-thalassemia patients which they expect to begin before the end of the year.

Siklos Now Available for Pediatric Patients With Sickle Cell Anemia

By August 21, 2018

Hydroxyurea, an antimetabolite, is thought to cause an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein.

Iron Therapies Compared in Patients With GI-Related Iron Deficiency Anemia

By July 30, 2018

The analysis also showed that the more severe the anemia was at baseline, the greater the response was to treatment with regard to hemoglobin changes.

<small>L</small>-Glutamine Reduces Number of Pain Crises in Sickle Cell Disease

July 19, 2018

The researchers found that there were significantly fewer pain crises in the L-glutamine group than in the placebo group, with a median of 3.0 and 4.0, respectively.

ESA Biosimilar Effective for Anemia in Hemodialysis Patients

July 13, 2018

Researchers found "no clinically meaningful differences" in efficacy and safety between the biosimilar epoetin alfa-epbx and epoetin alfa.

Olinciguat Granted Orphan Drug Status for Sickle Cell Disease

By June 08, 2018

Olinciguat is a soluble guanylate cyclase stimulator currently in Phase 2 development.

Mircera Approved to Treat Anemia in Pediatric Patients With CKD

By June 07, 2018

The approval was based on an open-label, multiple dose, multicenter, dose-finding study in 64 pediatric patients with CKD who were on hemodialysis and who had stable hemoglobin levels while previously receiving another ESA.

FDA to Review Promacta for First-Line Treatment of Severe Aplastic Anemia

By May 30, 2018

The FDA decision to grant Priority Review was based on results from a National Institute of Health (NIH) study which demonstrated a 52% complete response rate and an 85% overall response rate in treatment-naïve SAA patients treated with eltrombopag plus standard IST.

FDA Approves Epoetin Alfa Biosimilar Retacrit

By May 15, 2018

The approval of Retacrit was based on a review of evidence that included human pharmacokinetic/pharmacodynamic data and clinical immunogenicity data which demonstrated a high degree of similarity between Retacrit and its reference product.

IBD and Anemia: Adverse Events After IV Iron Therapy Examined

By April 23, 2018

To examine the occurrence of adverse reactions in this patient population, researchers from John Hopkins University, Baltimore, Maryland, conducted a retrospective analysis of IBD patients who received IV iron infusions between 2010 and 2014 in the commercial claims database, MarketScan.

Iron Formulation and Cancer Risk: Is There a Link?

By April 12, 2018

In the U.S., ferric citrate is commonly found in dietary supplements and ferric EDTA is often used as a food additive.

Oral vs. Intramuscular Vitamin B<sub>12</sub>: Efficacy, Safety Compared

By March 16, 2018

Researchers from Beijing University of Chinese Medicine and the Catalan Health Institute, Spain sought to investigate the effects of oral vitamin B12 vs. IM vitamin B12 to determine whether outcomes for vitamin B12 deficient patients would differ based on the formulation.

Antibiotic Prophylaxis Rates Low for Pediatric Sickle Cell Patients

February 06, 2018

Data were included for 2,821 children with 5,014 person-years. The researchers found that 18 percent of children received ≥300 days of antibiotics.

FDA Approves Expanded Use for Feraheme in Iron Deficiency Anemia

By February 05, 2018

The Food and Drug Administration broadened the existing labeling for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease indication.

Iron Dextran Injection Recall Expanded

By January 25, 2018

The recall was initiated due to product stability testing results that did not meet specifications for iron content.

Treating a Common Extraintestinal Manifestation of Inflammatory Bowel Disease

January 05, 2018

Mr. C, a 30-year-old male with Crohn's disease, presented to his clinician with symptoms of fatigue, lethargy, headaches, pallor, hair loss, irritability, and weakness.

Iron Deficiency Treatment in a Heart Failure Patient

December 11, 2017

A women with a 30-year history of hypertension, hyperlipidemia and an 8-year history of systolic dysfunction is hospitalized for congestion following a 5-day river cruise.

Possible New Marker of Kidney Disease Identified in Sickle Cell

December 05, 2017

Subsequently, 18 extracellular proteins were focused on, including CP, a protein involved in iron metabolism.

Incidence of Adverse Events Compared Among IV Iron Compounds

By December 04, 2017

It was also found that fewer all-cause ED visits or hospitalizations occurred in non-CKD patients (HR: 0.56; 95% CI: 0.45, 0.70) as well as in NDD-CKD patients (HR: 0.83; 95% CI: 0.71, 0.95) treated with ferumoxytol.

IV Iron Sucrose Evaluated for Iron Deficiency Anemia in Pediatric IBD

By December 01, 2017

Results of the review also found that 18 adverse events occurred in a total of 13 patients (18.1% of patients; 6.6% of infusions).

Ferric Carboxymaltose Tx Examined in Chronic HF Patients With Iron Deficiency

By December 01, 2017

Results demonstrated that both serum ferritin as well as transferrin saturation were significantly increased after FCM administration.

Frequency of Celiac Disease Testing Examined in Patients with IDA

By November 30, 2017

The subgroup that was most frequently tested was young Caucasian men, with 61% of respondents stating that they would implement serologic testing in this group.

Treating Iron Deficiency Anemia in Patients With Heart Failure

By November 16, 2017

To shed light on the often-challenging management of this common condition, MPR presented the case of a hypothetical patient to a doctor who specializes in advanced heart failure and transplant cardiology.

Auryxia Approved for Iron Deficiency Anemia in Patients With CKD

By November 07, 2017

At any point during the 16-week efficacy period, 52.1% (n=61/117) of the Auryxia treated group demonstrated hemoglobin levels of ≥1g/dL compared to 19.1% (n=22/115) of the placebo group.