Bleeding Disorders

FDA to Review Doptelet for Treatment of Chronic Immune Thrombocytopenia

By November 07, 2018

Doptelet is a thrombopoietin receptor agonist (TPO-RA) that was approved in May 2018 to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure.

BTK Inhibitor Designated Orphan Drug for Immune Thrombocytopenic Purpura

By October 19, 2018

PRN1008 is an oral, reversible covalent Bruton's tyrosine kinase (BTK) inhibitor; BTK is present in the signaling pathways of most types of white blood cells except for T cells and plasma cells.

Product Availability Update for Gammaplex Immune Globulin

By October 19, 2018

Gammaplex, an immune globulin, is indicated to treat chronic immune thrombocytopenic purpura (ITP) and primary humoral immunodeficiency.

Anavip Now Available for the Management of Rattlesnake Envenomation

By October 09, 2018

Anavip contains venom-specific F(ab')2 fragments of immunoglobulin G (IgG) that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body.

FDA Approves Expanded Indication for Hemlibra in Hemophilia A

By October 04, 2018

The expanded approval was based on data from two Phase 3 clinical trials: HAVEN 3 and HAVEN 4.

Patient Develops Acquired Hemophilia After Treatment With Levofloxacin

By September 27, 2018

Although discontinuation of the medication resolved the patient's symptoms initially, spontaneous bruising recurred and progressed over several weeks, prompting the patient to seek medical attention for persistent bruising in her upper extremities.

Labeling for Hereditary Factor X Deficiency Treatment Coagadex Updated

By September 26, 2018

In an open-label, non-randomized clinical trial, the use of Coagadex in routine prophylaxis of bleeding episodes was evaluated in 9 children <12 years of age.

FDA Approves New Stent System to Treat Acute Coronary Artery Perforations

By September 17, 2018

The Agency reviewed real-world data from 80 patients who received the PK Papyrus Stents, finding that the stents were delivered successfully to the perforation site in 95% of patients with successful seals seen in 73 patients 91.3% of patients.

Doptelet sNDA Submitted to FDA for Treatment of Immune Thrombocytopenia

By September 05, 2018

The sNDA includes safety and efficacy data from a Phase 3, randomized, placebo-controlled trial that met its primary efficacy endpoint of number of weeks with a platelet count ≥50x109/L in the absence of rescue therapy with high statistical significance.

Fostamatinib Seems Effective for Immune Thrombocytopenia

September 05, 2018

Forty-three percent of patients on fostamatinib and 14% on placebo achieved overall responses (defined as ≥1 platelet count ≥50,000/μL within the first 12 weeks on treatment).

Jivi With Step-Wise Dosing Approved for Management of Hemophilia A

By August 30, 2018

The approval was supported by data from the phase 2/3 international, open-label PROTECT VIII trial (N=126) that evaluated previously treated patients aged ≥12 years with severe hemophilia A.

Treatment Launched for Thrombocytopenia in Adults With Chronic Liver Disease

By August 30, 2018

Thrombocytopenia is a common complication of CLD, due to increased bleeding it can impact upon medical procedures. Mulpleta is supplied in 3mg strength tablets in blister packs containing 7 tablets.

Antidepressants and Bleeding Risk: What's the Link?

By August 08, 2018

Results showed an increased risk of bleeding with SRIs by 1.16-2.36 times with an even higher 3.17- to 10.9-fold risk with concomitant NSAIDs.

Mulpleta Approved for Thrombocytopenia in Patients With Chronic Liver Disease

By July 31, 2018

The approval was based on data from 2 randomized, double-blind, placebo-controlled trials (L-PLUS 1 [N=97] and L-PLUS 2 [N=215]) involving patients with chronic liver disease who were undergoing an invasive procedure and had a platelet count <50 x 109/L.

Most Bleeding Events in Non-CVD Patients Are GI-Related

June 28, 2018

The risk of a nonfatal GI bleeding event was 2.19 per 1,000 person-years in the baseline cohort, 1.77 in the non-high-risk cohort, and 1.61 in the nonmedication cohort.

Clotting Time in Transfemoral PCI Linked to Bleeding Risk

June 27, 2018

Researchers related maximal ACT to the risk of major bleeding in 14,634 patients undergoing TR or TF PCI with unfractionated heparin monotherapy.

Isolated mild/moderate thrombocytopenia may not require intervention

June 11, 2018

In a review of children who presented to a specialist hematology clinic with isolated mild or moderate low platelet counts, though causes were variable, most required no interventions.

Doptelet Now Available for Thrombocytopenia in Chronic Liver Disease

By May 31, 2018

The drug works by stimulating the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased production of platelets.

Larger Vial Size Approved for Hemophilia B Treatment Idelvion

By May 31, 2018

The new 3500 IU vial size will help shorten the reconstitution time needed to prepare multiple vials for a similar dose.

Tavalisse Now Available for Chronic Immune Thrombocytopenia

By May 29, 2018

Treatment with Tavalisse should be discontinued after 12 weeks if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.

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.