25 November 2013 | News | By BioSpectrum Bureau
Good news for patients with non-valvular atrial fibrillation (NVAF) - Pfizer and Bristol-Myers Squibb's apixaban stroke drug gets Singapore's Health Sciences Authority approval
Singapore: Health Sciences Authority (HSA) in Singapore has approved new treatment, apixaban (Eliquis), marketed by pharmaceutical companies Pfizer and Bristol-Myers Squibb (BMS), to reduce the risk of a first or recurrent stroke in patients with non-valvular atrial fibrillation (NVAF).
Apixaban is an oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause death.
Atrial fibrillation (AF), which is an abnormal heart rhythm, poses a large threat to Singapore's ageing population as it increases the risk of stroke by almost five times when compared with a normal heart rhythm (sinus rhythm). Local statistics show that AF afflicts as many as one-in-20 people over the age of 65, while the lifetime risk of developing AF is estimated to be approximately 25 percent for individuals 40 years of age or older.
AF related strokes tend to be more severe than other strokes with an associated 30-day mortality of 24 percent and a 50 percent likelihood of death within one year.
"AF-related strokes can leave their victims disabled and dependent," explained Dr Deidre Anne De Silva, president, Singapore National Stroke Association and a consultant with the Department of Neurology at the National Neuroscience Institute (SGH campus). "Survivors of AF-related strokes may have to live with long-term physical, cognitive, psychological and social consequences which impact not just the patients, but also their families and caregivers," she said. AF is associated with at least 15 percent of all strokes.
"More attention needs to be given to AF-related strokes. With proper management, the risk of AF-related strokes can be potentially reduced. There are medications which prevent the formation of blood clots in the heart and their migration to the brain which causes AF-related stroke. Many patients with AF are not treated with these medications because they do not even know they have AF as it is often asymptomatic and can only be detected through screening," concluded Dr De Silva.
Apixaban is approved to reduce the risk of a first or recurrent stroke or systemic embolism in patients with NVAF. It does not require INR monitoring, has no known dietary restrictions and can be taken with or without food.
"Pfizer and BMS are pleased to collaborate to bring an innovative new treatment to reduce the risk of stroke in patients with atrial fibrillation (AF) to the market" said Ms Christina Teo, country manager, Pfizer Singapore.
"The management and treatment of AF-related stroke has evolved in recent years, and we hope to decrease the incidence of stroke with apixaban," added Mr Binh Thai, general manager, Bristol-Myers Squibb, Singapore.