Bleeding Disorders

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.

FDA Approves Additional Vial Strengths of Nuwiq for Hemophilia A

By August 22, 2017

In addition to the currently available strengths (250, 500, 1000, 2000 IU), starting in September, Nuwiq will also be supplied in 2500, 3000, and 4000 IU vial strengths.

Caplacizumab Fast-Tracked for Acquired Thrombotic Thrombocytopenic Purpura

By July 26, 2017

The Phase 2 TITAN study (n=75) evaluated the safety and efficacy of caplacizumab with standard of care of plasma exchange and immunosuppression.

Idarucizumab Effective for Dabigatran Reversal in Emergency Situations

July 13, 2017

Effective for dabigatran reversal among patients with uncontrolled bleeding, undergoing urgent surgery

Emicizumab Beneficial in Hemophilia A Patients With Inhibitors to FVIII

By June 29, 2017

The primary analysis of the study arm showed a statistically and clinically significant reduction in bleeding by 87% (risk rate [RR] 0.13; P<0.0001] with emicizumab prophylaxis.

NDA Filed for Tavalisse for Immune Thrombocytopenia Treatment

By June 19, 2017

Tavalisse is an oral treatment designed to inhibit SYK kinase, a key signaling member in the immune process that leads to platelet destruction in ITP.

PPIs May Benefit Older Patients on Antiplatelet Therapy

June 15, 2017

Research suggests proton-pump inhibitors should be co-prescribed in patients age 75 years

Anticoagulation During Pregnancy Linked to Distinct Maternal, Fetal Risks

June 02, 2017

VKA, LMWH tied to lowest risk of adverse maternal, fetal outcomes, respectively

Rebinyn Approved to Treat Hemophilia B

By June 01, 2017

Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate, temporarily replaces the missing coagulation Factor IX in hemophilia B patients.

Novel Hemophilia A Gene Therapy Gets Fast Track Status

By May 16, 2017

The Food and Drug Administration (FDA) has granted Fast Track designation to SB-525 (Sangamo Therapeutics) for the treatment of hemophilia A.

FDA to Review Fostamatinib for Chronic, Persistent ITP

By April 18, 2017

Rigel announced its submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenic purpura (ITP).

Emicizumab Evaluated in Children with Hemophilia A

By April 17, 2017

The interim results from HAVEN 2, after a median of 12 weeks of treatment, showed that prophylaxis with emicizumab is associated with clinically meaningful reduction in the number of bleeds over time.