Bleeding Disorders

Extended INR Test Intervals Safe for Warfarin-Treated Patients

May 23, 2018

Similar number of out-of-range next INR values for patients with, without extended testing interval

Doptelet Approved for Chronic Liver Disease Patients With Thrombocytopenia

By May 21, 2018

The approval of Doptelet was based on results from the ADAPT-1 (N=231) and ADAPT-2 trials (N=204), 2 identically-designed multicenter, randomized, double-blind, placebo-controlled studies.

First Generic Alternative for Mephyton Now Available

By May 15, 2018

Amneal's generic product is available in a 5mg strength tablet supplied in 100-count bottles.

FDA Approves Hemospray to Treat Non-Variceal GI Bleeds

By May 09, 2018

The product is a single-use device that delivers hemostatic powder through the channel of an endoscope.

Andexxa Approved for Reversing Anticoagulant Activity of Rivaroxaban, Apixaban

By May 04, 2018

Andexxa, a recombinant modified human Factor Xa (FXa) protein, was approved under the FDA's Accelerated Approval pathway.

Gene Therapy Looks Promising for Transfusion-Dependent β-Thalassemia

By April 19, 2018

The safety and efficacy of LentiGlobin were evaluated in 2 independent 2-year clinical studies: HGB-204 (Northstar, N=18), an open-label, single-dose, nonrandomized, multicenter Phase 1/2 study in patients with TDT, and HGB-205, an ongoing open-label, single-dose, nonrandomized, single-center Phase 1/2 study in patients with TDT and severe sickle cell disease.

First-in-Class Treatment Approved for Chronic Immune Thrombocytopenia

By April 18, 2018

Tavalisse is an oral spleen tyrosine kinase (SYK) inhibitor.

Hemlibra Gets Breakthrough Tx Status for Hemophilia A Without Inhibitors

By April 18, 2018

The trial enrolled 152 patients with hemophilia A who were previously treated, either on-demand or as prophylaxis, with factor VIII therapy.

Praxbind Gains Full FDA Approval as Pradaxa Reversal Agent

By April 17, 2018

Complete reversal was seen within 4 hours in the majority of patients, as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%). In addition, there was a low late of thrombotic events and no new safety events were reported.

Vonvendi Approved for Peri-Operative Management of Bleeding in VWD Patients

By April 17, 2018

Safety and efficacy of Vonvendi with or without recombinant factor VIII (FVIII) treatment in elective surgical procedures in patients aged ≥18 years diagnosed with severe von Willebrand disease, was established in the Phase 3 trial.

Certain Lots of Kcentra Recalled Due to Potential Risk of Vial Breakage

By April 06, 2018

The recall notification is due to a potential risk of breakage of the glass vials during transport because of a change in the secondary packaging configuration.

Comparative Safety of NSAIDs Among Clopidogrel Users Investigated

By March 15, 2018

Using Medicaid claims from 5 states (1999-2010) and Medicare claims for dual-enrollees, study authors analyzed the first concomitant use of clopidogrel and 1 of 10 selected NSAIDs (ibuprofen, celecoxib, naproxen, rofecoxib, meloxicam, diclofenac, indomethacin, valdecoxib, nabumetone, etodolac) after a 1-year baseline period.

Interim Data Show Andexanet Alfa Rapidly Reverses Anti-Factor Xa Activity

By March 13, 2018

ANNEXA-4 is a global, single-arm, open-label clinical trial designed to evaluate andexanet alfa in patients who present with an acute major bleed while receiving apixaban, rivaroxaban, edoxaban or enoxaparin.

Pharmacokinetic Dosing Software for Hemophilia A Treatment Now Available

By March 05, 2018

The myPKFiT software can be used to generate Advate dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16yrs of age and older and body weight of 45kg or greater.

BLA for Extended Half-Life Factor VIII Hemophilia A Tx Filed With FDA

By February 27, 2018

N8-GP (turoctocog alfa pegol) is a glycopegylated form of turoctocog alfa designed for prolonged half-life.

Lusutrombopag Under Priority Review for Thrombocytopenia in Liver Disease

By February 26, 2018

The primary endpoint was the number of patients who required no platelet transfusion priory to primary invasive procedure and no rescue therapy for bleeding for 7 days post-procedure.

Rebinyn Now Available for the Treatment of Hemophilia B

By February 08, 2018

Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate with an extended half-life, was approved by the Food and Drug Administration (FDA) in May 2017.

Results Released in Multi-Year IV Bevacizumab Study for HHT-Related Bleeding

February 05, 2018

After completion of the initial bevacizumab treatment cycle, there was a significant reduction in epistaxis severity scores and RBC transfusion requirements.

FDA Lifts Hold on Potential Hemophilia Treatment

By December 15, 2017

Fitusiran, an RNAi therapeutic targeting antithrombin (AT), is designed to lower levels of AT in order to further sufficient thrombin generation to restore hemostasis and prevent bleeding.

Gene Therapy Shows Promise in Factor IX Coagulant Activity for Hemophilia B

December 07, 2017

In all participants, vector-derived factor IX coagulant activity was sustained, with a mean steady-state factor IX coagulant activity of 33.7 ± 18.5%.

ACC: New Guidance on Managing Bleeding in Patients on Oral Anticoagulants

December 04, 2017

At each step, patient specific factors should be considered.

Hemophilic Arthropathy Treatment Gets Orphan Drug Designation

By November 27, 2017

TRM-201 (rofecoxib) is a highly potent COX-2 selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile.

Alprolix Labeling Updated With Long-Term Data, Additional Adverse Reaction

By November 27, 2017

Alprolix is a recombinant clotting factor therapy developed using Fc fusion technology to prolong circulation in the body.

Hemlibra Approved to Treat Hemophilia A With Inhibitors

By November 16, 2017

Hemlibra is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Effect of Treatment Delay With Tranexamic Acid Examined

November 08, 2017

Overall, 63% of bleeding deaths occurred within 12 hours of onset. There was a peak in deaths from postpartum hemorrhage at 2 to 3 hours after childbirth.

BLA for Investigational Hemophilia A Treatment Accepted

By October 31, 2017

BAY94-9027 is designed to prolong FVIII activity in the blood while preserving coagulation activity using site-specific technology in which the Polyethylene glycol molecule is consistently attached to the factor VIII protein at a specific site.

Voluntary Market Withdrawal of Octagam 10% Announced

By October 23, 2017

The Company has decided in conjunction with the FDA to suspend further administration of Octagam 10% from these specific production lots.

Anticoagulants Taken With Certain Meds May Up Bleeding Risk

October 05, 2017

And antithrobotic medications linked to higher rate of hematuria-related events in older adults

Prophylaxis vs. On Demand Tx in Patients with Severe Hemophilia

August 31, 2017

Overall, 35.7% of prophylaxis participants were bleed-free and 76.2% had fewer than 2 BEs per year.

BLA for Novel Hemophilia A Therapy Granted Priority Review

By August 24, 2017

The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) of emicizumab (Genentech) for the prophylactic treatment of hemophilia A in adults, adolescents and children with factor VIII inhibitors.