First positive health technology assessments for novel oral anticoagulant Pradaxa®

Boehringer IngelheimThe Scottish Medicines Consortium (SMC) has accepted Pradaxa® (dabigatran etexilate) for routine use within the National Health Service (NHS) of Scotland for its currently licensed indication: the prevention of venous thromboembolic events in adults who have undergone total hip or knee replacement surgery. The European Commission granted marketing authorisation for Pradaxa® in all 27 EU member states in March 2008.

Also the Danish Institute for Rational Pharmacotherapy (IRF) which belongs to the Danish Medicines Agency has endorsed Pradaxa® as a good alternative to low molecular weight heparins (LMWH) both with respect to efficacy and ease of use.

These decisions on Pradaxa® are the first by European health technology assessment bodies and their positive outcomes are likely to be viewed favourably by decision makers considering the implementation and reimbursement of Pradaxa® across the EU as they indicate Pradaxa® has fulfilled all clinical and cost-effectiveness criteria necessary for use within the NHS in Scotland and clinical criteria necessary for use in Denmark.

Data from the phase III RE-NOVATE™ and RE-MODEL™ studies showed oral, once daily administration of both 150 and 220 mg Pradaxa® was as effective and safe as injectable enoxaparin (40 mg) in preventing venous thromboembolism (VTE) and all cause mortality following total hip and total knee replacement surgery. In contrast to low molecular weight heparins (LMWH), which require subcutaneous injection, Pradaxa® is administered as a fixed, oral dose making it significantly easier to administer both in the hospital setting and, more importantly, in the home setting after discharge. Unlike both LMWH and warfarin, Pradaxa® does not require monitoring.

Patients undergoing hip and knee replacement surgery are at particularly high risk of developing VTE. Without thromboprophylaxis, up to 60 percent of orthopaedic surgery patients have been shown to develop DVT (deep vein thrombosis; including asymptomatic thrombi), and 0.2-10 percent are at risk of a potentially fatal PE (pulmonary embolism) according to previous studies. It is estimated that 543,454 deaths in Europe per year are VTE-related, more than double the number from breast cancer, prostate cancer, HIV/AIDS and road traffic accidents combined.

Professor Simon Frostick, Professor of Orthopaedics at the University of Liverpool, UK said: "We know that thromboprophylaxis after orthopaedic surgery is crucial to protect patients from potentially life-threatening thrombi. Now, with Pradaxa® as a new therapeutic option, we have an effective oral, once-daily anticoagulant with a good efficacy and safety profile to facilitate convenient thromboprophylaxis both in and out of hospital."

The registered charity AntiCoagulation Europe (ACE) which works to prevent thrombosis and provide information for patients also welcomed the decision. Executive Director Eve Knight said: "This could mean saving lives. Pradaxa® is potentially a huge benefit for patients. One of the reasons why patients are not given thromboprophylaxis is that they have to have heparin which has to be injected. Following hospital discharge, many patients have to learn to self-inject which may result in inadequate treatment duration due to poor compliance. Pradaxa® is so much more convenient; just two capsules once a day."

Pradaxa® has a rapid onset and offset of action and a predictable anticoagulation effect. It prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme in the coagulation cascade that enables conversion of fibrinogen into fibrin. In contrast to warfarin, Pradaxa® exhibits no drug-food interactions and has a low potential for drug-drug interactions.

Boehringer Ingelheim continues to evaluate the efficacy and safety of Pradaxa® in a range of thromboembolic disease conditions. RE-VOLUTION™ is an extensive clinical trial programme involving more than 38,000 patients worldwide. Recent progress includes the announcement in January 2008 of the completion of enrolment of 18,114 patients in RE-LY™, the largest stroke prevention atrial fibrillation outcomes trial to date. Other ongoing studies are evaluating the efficacy and safety of Pradaxa® in the treatment of acute VTE, the secondary prevention of VTE and prevention of cardiac events in patients with acute coronary syndrome.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

For more information, visit www.boehringer-ingelheim.com.

Most Popular Now

Salvat Laboratories announces submission of New Dr…

Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsi...

Pfizer's elranatamab granted FDA Breakthrough Ther…

Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administrati...

New insights on antibody responses to Omicron vari…

Knowing how well vaccination against one SARS-CoV-2 strain (with or without previous infection) counteracts infection with a different strain is a critical research quest...

The origin-of-life molecule, a key to cancer resea…

RNA, the molecule that gave rise to life, has been shown to be essential for repairing human genetic material and preventing mutations that might lead to developing cance...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...

New drug shows promise for fighting both COVID-19 …

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot ...