The safety and efficacy of Ultomiris in patients with PNH was assessed in 2 open-label, randomized, active-controlled, non-inferiority Phase 3 studies.
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.
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.
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.
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.
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.
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.
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.
Researchers found "no clinically meaningful differences" in efficacy and safety between the biosimilar epoetin alfa-epbx and epoetin alfa.
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.
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.
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.
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.
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.
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.
The Food and Drug Administration broadened the existing labeling for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease indication.
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.
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.
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.
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).
Results demonstrated that both serum ferritin as well as transferrin saturation were significantly increased after FCM administration.
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.
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.
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.