Inhixa (enoxaparin biosimilar) / Techdow - LARVOL DELTA

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=179 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

INHIXACOV19: Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients (clinicaltrials.gov) - P2 | N=301 | Completed | Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna | Unknown status ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

"Techdow USA Announces FDA Approval of Generic Lovenox®, (Enoxaparin Sodium – Preservative Free) In Prefilled Syringes https://t.co/Teu2pmdwZ2" (@NewsFromBW)

FDA event

[VIRTUAL] Evaluation of the Efficacy and Safety of Enoxaparin Biosimilar Treatment in Our Center (ISTH 2021) - "Treatment should be personalized according to each patient.Further studies will provide more confirmatory data. Biosimilar drugs have the potential to offer the National Health System cost savings and expand access to therapeutic innovations."

Clinical • Allergy • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Thrombosis • Venous Thromboembolism

[VIRTUAL] EXPERIENCE IN THE USE OF BIOSIMILAR ENOXAPARIN SODIUM FOR PROPHYLAXIS AND TREATMENT OF VENOUS THROMBOEMBOLIC DISEASE IN OUR HOSPITAL (EHA 2021) - "Bridging therapy consisted of suspending VKA from 4 (acenocoumarol) to 6 days (warfarin) before the procedure and substitution with biosimilar enoxaparin sodium: 1.5 mg / kg / 24 h, and administration of a prophylactic dose 4,000 IU, 12 hours before of the procedure, and another dose 6-12 hours after it, depending on the risk of bleeding from the intervention and the thrombotic risk of the patient's underlying disease. Further studies will provide more confirmatory data. Biosimilar drugs have the potential to offer the National Health System cost savings and expand access to therapeutic innovations."

Clinical • Allergy • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Oncology • Thrombosis • Venous Thromboembolism

STAUNCH-19: Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection (clinicaltrials.gov) - P3; N=210; Recruiting; Sponsor: Massimo Girardis; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Safety and effectiveness of biosimilar enoxaparin (Inhixa) for the prevention of thromboembolism in medical and surgical inpatients. (PubMed, Intern Emerg Med) - "The incidence of thrombotic events was 0.6% (IC 95%: 0.2-1.8) and 0.7% (CI95% 0.3-1.6), respectively. The incidence of bleeding and thrombosis in medical and surgical patients receiving Inhixa was low suggesting biosimilar enoxaparin is a valid alternative to branded enoxaparin."

Clinical • Journal • Cardiovascular • Hematological Disorders • Venous Thromboembolism

Use of Enoxaparin to Counteract COVID-19 Infection and Reduce Thromboembolic Venous Complications: A Review of the Current Evidence. (PubMed, Front Pharmacol) - "The available evidence suggests that LMW heparin appears as a promising tool in the treatment of COVID-19. Whether its systematic use is associated with a reduction in complications and ultimately mortality of these patients is being tested in several studies starting worldwide."

Journal • Review • Cardiovascular • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease

STAUNCH-19: Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection (clinicaltrials.gov) - P3; N=210; Not yet recruiting; Sponsor: Massimo Girardis

New P3 trial • Hematological Disorders • Hemophilia • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

[VIRTUAL] Biosimilar Enoxaparin Sodium Inhixa® Compared with Clexane®: An in vitro Study (ISTH 2020) - "In vitro anti-FXa activity of Clexane® and Inhixa® showed very good correlations with a small underestimation of Inhixa®, lower than anti-FXa intra/inter assay variability. Limits are represented by the “in vitro” evaluation that cannot give any information respect “in vivo” pharmacokinetic, pharmakodynamic, clinical efficacy, safety and collateral effect as immunogenic reactivity. A strict pharmacovigilance should be recommended and anti-FXa monitoring, at least in particular clinical settings, should be advised."

Preclinical

Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol. (PubMed, Trials) - P3 | "To assess whether high doses of Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (i.e., Enoxaparin 4000 IU once day), in hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV], are: a)more effective in preventing clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were receiving standard oxygen therapy5.IMV in patients who at randomisation were receiving non-invasive mechanical ventilationb)Similar in terms of major bleeding risk TRIAL DESIGN: Multicentre, randomised controlled, superiority, open label, parallel group, two arms (1:1 ratio), in-hospital..."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Hemophilia • Immunology • Infectious Disease • Myocardial Infarction • Novel Coronavirus Disease • Oncology • Ophthalmology • Peptic Ulcer • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia • Venous Thromboembolism

Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design. Steroidi e eparina non frazionata in pazienti critici con polmonite da COVID-19. Disegno di studio multicentrico, interventistico, randomizzato con tre bracci. (clinicaltrialsregister.eu) - P3; N=200; Ongoing; Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalised patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD) Studio randomizzato controllato sull’efficacia e sulla sicurezza di alte verso basse dosi di eparina a basso peso molecolare in pazienti ricoverati... (clinicaltrialsregister.eu) - P3; N=300; Ongoing; Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA

Clinical • New P3 trial • Hematological Disorders • Hemophilia • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

INHIXACOV19: Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

COVID-19 HD: High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy (clinicaltrials.gov) - P3; N=300; Not yet recruiting; Sponsor: Azienda Ospedaliero-Universitaria di Modena

Clinical • New P3 trial • Hematological Disorders • Hemophilia • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases