20. December 2011 11:14
The European Commission has granted approval for two new indications in the UK for Bayer HealthCare’s Xarelto (rivaroxaban).
The oral anticoagulant has been approved for the prevention of stroke and non-CNS systemic embolism in adults with non-valvular atrial fibrillation (AF) and one or more risk factors for stroke and for the treatment of deep vein thrombosis (DVT).
AF, the most common sustained cardiac rhythm disorder, affects around 750,000 people in the UK. In England each year, more than 25,000 people die from DVT contracted in hospital.
Xarelto is already indicated in the UK to help prevent VTE in patients undergoing elective total hip or knee replacement surgery. It’s believed to have been used in more than 100,000 patients in the UK and has treated more than a million patients worldwide for this indication.
The latest indication for the prevention of stroke and non-CNS systemic embolism was based on the results from ROCKET AF trial which demonstrated consistent findings.
NICE Guidelines recommend oral anticoagulants for the majority of AF patients to prevent stroke. However, current treatment options, such as warfarin, have limitations that challenge both healthcare professionals and patients. It is subject to potential limitations including unpredictable anticoagulant effects and can interact with numerous drugs and a wide array of food and drink in certain patients.
Xarelto is the first in a class of non-VKA anticoagulants called Factor Xa inhibitors. It offers a convenient oral dosing and a lower risk of interactions with other drugs compared with VKA antagonists, such as warfarin.
“Treatments which act at a key point in the blood-clotting process are now emerging as an important therapy option in both short and long-term clinical settings, and have the potential to help re-shape clinical practice,” said Professor Keith Fox, Professor of Cardiology at the University of Edinburgh.
10. November 2011 14:16
The FDA has again extended the indication for Erbitux (cetuximab) and approved the treatment for patients with advanced head and neck cancers in combination with chemotherapy.
The extension is based on the EXTREME study of 442 patients previously untreated with chemotherapy that demonstrated those treated with Erbitux lived 10.1 months on average, compared with 7.4 months on those treated with chemotherapy alone.
Richard Pazdur, Head of Oncology, FDA, says the medication is an “important tool” for doctors and patients.
Erbitux is now approved for five separate indications across two tumour types and becomes the first regimen in 30 years with extended overall survival in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck to be approved.
8. November 2011 16:11
Pfizer’s Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, Adsorbed]) has been launched in the UK for active immunisation of invasive disease caused by Streptococcus pneumoniae in adults aged 50 and over.
It becomes the first and only pneumococcal conjugate vaccine to be licensed for adults aged 50 and over after gaining a new indication from the EMA.
Dr George Kassianos, GP and immunisation lead for the Royal College of GPs and the British Travel Health Association, says its introduction is an “important achievement and step forward” for adult patients.
The vaccine was first licensed for infants and young children in December 2009 in Europe and used during the UK’s Childhood Immunisation Schedule in April last year.
The new indication provides a new treatment option for the prevention of adult invasive pneumococcal disease (IPD), which includes the potentially fatal bacteraemic pneumonia, meningitis and septicaemia.
Chris Head, CEO of the Meningitis Research Foundation, welcomed the vaccine’s launch in the UK. “The new license for Prevenar 13 provides an opportunity to protect adults over 50, who are more at risk of serious pneumococcal disease than younger adults,” he said.
Until Prevenar 13’s new indication, adults over 65 and those in clinical risk groups were treated with the pneumococcal polysaccharide vaccine. But in clinical trials, patients given Prevenar 13 had significantly higher antibody responses with the vaccine expected to protect against seven out of the most ten most comment serotypes which causes IPD.