AstraZeneca responds to FDA advisory committees’ recommendation on SYMBICORT
For the brain to achieve its intricate functions such as perception, action, attention and decision making, neural regions have to work together yet still retain their specialized roles. Excess or lack of timely coordination between brain areas lies at the core of a number of psychiatric and neurological disorders such as epilepsy, schizophrenia, autism, Parkinson’s
Full Post: Dynamical theory and novel 4-D colorimetric method reveal modus operandi of intact living brain
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 that the benefits of AstraZeneca’s SYMBICORT(R) (budesonide/formoterol fumarate dihydrate), a combination LABA/Inhaled Corticosteroid (ICS) medication, outweigh the risks in adult and adolescent asthma patients.
Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said, “The safety and efficacy of SYMBICORT have been demonstrated in numerous clinical trials and from extensive post-marketing use around the world. We are pleased that the joint advisory committees’ recommendation confirms our view on the positive benefit-risk profile of SYMBICORT.”
The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.
About SYMBICORT in the U.S.
SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) is approved in over 100 countries for the long-term maintenance treatment of asthma and is available in two different inhalers, SYMBICORT TURBUHALER and in the U.S. as SYMBICORT pMDI.
SYMBICORT is a combination therapy indicated in the U.S. for the long-term maintenance treatment of asthma in patients 12 years of age and older. SYMBICORT should not be used in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta2-agonists. Administered twice daily, SYMBICORT is a combination of two proven asthma medications-budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.
Important Safety Information
Long acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT.
SYMBICORT is not indicated for the relief of acute bronchospasm.
SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.
Particular care is needed for patients who are transferred from systemically active corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Patients who are receiving SYMBICORT twice daily should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.
Common adverse events reported in clinical trials, occurring in less than or equal to 5 percent of patients, regardless of relationship to treatment, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.
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
Full Post: GlaxoSmithKline statement on FDA advisory committee vote on use of asthma medicines containing long-acting beta agonists
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
Mylan Inc. has announced that its subsidiary Dey L.P. has been issued several additional U.S. patents protecting the company’s Perforomist(R) Inhalation Solution, a chronic obstructive pulmonary disease (COPD) treatment. U.S. Patent No. 7,462,645 was issued Dec. 9, 2008, and is directed to treatment through the administration of a ready-to-use, storage stable composition of formoterol. This
Full Post: Dey L.P. issued new U.S. patents for Perforomist inhalation solution
Daiichi Sankyo Company, Limited and Eli Lilly and Company has confirmed that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during an advisory committee hearing on February 3, 2009. Prasugrel is an investigational antiplatelet agent for the treatment of patients with acute coronary syndromes (ACS) who
Full Post: FDA to review prasugrel for acute coronary syndromes
GlaxoSmithKline (GSK) is prepared to respond to public health needs for Relenza (zanamivir) Inhalation Powder this flu season following a Health Alert Advisory issued by the Centers for Disease Control and Prevention (CDC). Relenza is a preferred medication in the CDC-issued interim recommendations for all circulating subtypes of influenza virus. This interim guidance is based
Full Post: GlaxoSmithKline ready to supply Biota’s Relenza to meet CDC recommendations