Today, Allergan Inc. announced that BOTOX(R)has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic overactive bladder (OAB) with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medications.This is an important step towards securing national licences in the 14 European countries involved in the Mutual Recognition Procedure and marks a key milestone in bringing this innovative treatment to patients suffering from idiopathic OAB. The positive opinion is specific for BOTOX(R) and is based on Allergan's successful global phase III programme in idiopathic OAB.
Idiopathic overactive bladder is surprisingly common in Europe, with studies indicating that up to 16.6% of the population may have the condition.[1],[2] Of these, up to 36% will experience urinary incontinence (leaking) associated with urgency.[1] Two multi-national studies report that between 16-28% of idiopathic OAB patients receive a prescription medication to manage their condition.[3],[4] However, research also indicates that more than 50% of patients stop taking at least one oral medication within 12 months, likely due to lack of efficacy or side-effects.[5],[6]Idiopathic OAB can be a disabling and socially isolating condition, considerably affecting daily activities, work-life, mental health and sleep quality, thus reducing patients' quality of life.[7] It can negatively impact emotional well-being, causing embarrassment, low self esteem, depression and loss of independence.[8]
"We are pleased that BOTOX(R) has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic OAB in patients who are struggling to control their bladder symptoms with anticholinergic medications. For these patients, gaining effective control over their bladder without the fear of leakage after only one treatment can be a significant step towards improving quality of life," said Douglas Ingram, President of Allergan in Europe, Africa and the Middle East. "This is a critical milestone for the organisation, extending our commitment to urology beyond neurogenic detrusor overactivity and building on our long-term commitment to innovation in botulinum toxin research. Our task now is to work closely with the national health authorities in Europe to secure the relevant national licences so that we can bring this valuable treatment option to patients, as quickly as possible."
The positive opinion is based on the results of two randomised, placebo-controlled, multi-centre, phase III trials (the EMBARK studies) involving over 1,100 patients.[9] In these studies, patients who received targeted injections of BOTOX(R) (100 Units) into the bladder muscle experienced a significant and clinically relevant response to treatment compared to placebo in the reduction of urinary incontinence, including more patients becoming dry (no urinary leakage at 12 weeks). Significant improvements compared with placebo were also observed for all other symptoms of idiopathic OAB. Patients treated with Allergan's botulinum toxin type A product reported significant improvements in their quality of life compared to patients treated with placebo. In these studies, Allergan's botulinum toxin type A product was generally well tolerated. The most common adverse events reported were urinary tract infection and dysuria (painful urination).[9]
"There are currently very limited treatment options for idiopathic OAB patients who have not achieved bladder control with existing anticholinergic medications. Many patients find these daily medications are difficult to adhere to and sometimes have limited effect, and they continue to live with the potentially debilitating impact of their condition," said Professor Christopher Chapple, Urology Department, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust and a key investigator in the idiopathic overactive bladder registration trials. "There is a need for additional treatments that are effective, well-tolerated, minimally invasive options to help patients gain better control of these distressing symptoms."
La Federación Española de Empresas de Tecnología Sanitaria (Fenin) ha reelegido a Daniel Carreño como presidente tras la celebración de la Asamblea Electoral de la Federación.
Durante este mes se suceden las comidas, cenas y quedadas navideñas. Unos momentos en los cuáles muchas personas descuidan su alimentación y se despreocupan del tipo de comida que ingieren y es ahí donde aumenta el riesgo de sufrir reacciones alérgicas a alimentos. Según los datos de la EAACI (Academia Europea de Alergia e Inmunología Clínica) en la próxima década más de la mitad de la población europea estará expuesta a la aparición de alguna forma de alergia durante su vida.
