GlaxoSmithKline statement on FDA advisory committee vote on use of asthma medicines containing long-acting beta agonists
Individuals who were underweight at birth are at increased risk of developing a condition called secondary focal segmental glomerulosclerosis, according to a study appearing in the January 2009 issue of the Clinical Journal of the American Society Nephrology ( CJASN ). Because birth history is often overlooked by kidney specialists who take care of adult
Full Post: Low birth weight a risk factor for focal segmental glomerulosclerosis
The following is GlaxoSmithKline’s statement regarding recommendations of a combined Advisory Committee to the FDA on the use of asthma medicines containing long-acting beta agonists, including GSK’s Serevent (salmeterol) and Advair (salmeterol/fluticasone proprionate).
“We welcome the committee’s endorsement of Advair as a safe and effective treatment for asthma in adults and children,” said Dr. Ellen Strahlman, Chief Medical Officer for GSK. “We believe this recommendation is consistent with national treatment guidelines — based on evidence and developed by experts — that support the combination of a LABA and ICS as a preferred treatment for children and adults with persistent asthma. We will continue to work with physicians to encourage broader understanding of national guidelines for appropriate use.”
“Serevent, when used with an ICS, is an important treatment option for some patients as outlined in national guidelines. We are confident that our proposed new labeling, medication guide and risk management plan would help physicians safely manage the appropriate use of Serevent in conjunction with an ICS,” Dr. Strahlman said. “We are concerned that — if the FDA adopts the panel’s recommendation on Serevent — it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma.”
GSK is committed to continuing discussions with the Agency as it determines next steps following the Advisory Committee meeting.
GSK conducted an analysis of more than 200 clinical studies that included more than 100,000 patients, presenting the following information to the committees:
– The clinical and observational data presented by GSK demonstrated better overall asthma control with Advair than with a single medicine. Improvements with Advair included better lung function and symptom control and a reduction in albuterol use.
- For Advair, there was no evidence of increased risk for asthma-related death, hospitalization, and intubation as well as all cause death in any age group compared to other treatments studied.
- The analysis showed no increased risk of serious asthma-related events when salmeterol is used appropriately with an ICS. In fact, the combination of salmeterol with an ICS (either as Advair or as Serevent plus an ICS) provides effective asthma control to patients by improving lung function, preventing daytime and nighttime symptoms and decreasing the use of rescue medications — all important measures of asthma control.
- There were no asthma-related deaths in children receiving Serevent or Advair in clinical studies enrolling more than 7,400 children.
- There was an increased risk for serious asthma-related outcomes, including hospitalization, when salmeterol was used without an inhaled corticosteroid or when the use of inhaled corticosteroids could not be assured (e.g. not part of study treatment).
- Asthma is a significant public health issue in the U.S. The disease affects more than 22 million people, including more than 6 million children. Uncontrolled asthma can put patients at risk for increased asthma symptoms, sudden attacks, hospitalization and death.
Important Information about Advair Diskus
Advair Diskus is indicated for the maintenance treatment of asthma. Advair Diskus won’t replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. Advair Diskus contains salmeterol. In patients with asthma, medicines like salmeterol may increase the chance of asthma-related death. So Advair Diskus is not for people whose asthma is well controlled on another controller medicine. People should speak to their doctor about the risks and benefits of treating their asthma with Advair Diskus. People taking Advair Diskus should see their doctor if their asthma does not improve. People should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. Advair Diskus is for patients 4 years and older. For patients 4 to 11 years old, Advair Diskus 100/50 is for those who have asthma symptoms while on an inhaled corticosteroid.
Important information about Serevent Diskus
Serevent Diskus is indicated for the maintenance treatment of asthma in patients 4 years of age and older. Serevent Diskus does not replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. In patients with asthma, medicines like Serevent may increase the chance of asthma-related death. People should talk to their doctor about this risk and the benefits of treating their asthma with Serevent Diskus. Serevent Diskus should not be the only controller medicine prescribed for a person’s asthma and is not a substitute for anti-inflammatory medications (inhaled or oral corticosteroids). People should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. People should see their doctor if their asthma does not improve.
On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs). The committees concluded
Full Post: AstraZeneca responds to FDA advisory committees’ recommendation on SYMBICORT
Death from asthma is uncommon. Available mortality statistics for the United States indicate a death rate of approximately 0.3 per 100,000 persons. The available information on the clinical course of asthma suggests that somewhere between 50 to 80 percent of all patients can expect to have a reasonably good prognosis, particularly those whose disease is mild
Full Post: Asthma
Data presented today at the American College of Allergy, Asthma & Immunology (ACAAI) show that Xolair (Omalizumab) for Subcutaneous Use significantly reduced asthma attacks in children aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids. The study further defines the safety profile of Xolair in this patient population.
Full Post: Xolair (Omalizumab) shows promise in treating allergic asthma inadequately controlled by inhaled corticosteroid
The need for an urgent change in asthma management is advocated this week by a group of respiratory specialists, patient representatives, GPs and paediatricians from across Europe and North America. Writing in the December issue of the European Respiratory Journal (ERJ), the group, which includes Professor Stephen Holgate, Medical Research Council Professor of Immunopharmacology at
Full Post: Experts urge change in asthma management
Up to 150,000 people suffering from severe asthma in the UK could benefit from taking antifungal medication already available from pharmacists, new research has found. University of Manchester scientists found that pills used to treat everyday fungal infections greatly improved symptoms of asthma in those patients that had an allergic reaction to one or more
Full Post: Antifungal medication could provide asthma relief for 150,000 UK sufferers