March 21st 2022
Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.
April 16th 2014
Sublingual immunotherapy for allergic rhinitis and asthma effective, JAMA reports
April 2nd 2013In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by FDA, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to a review article in the March 27 issue of JAMA.
Leukotriene inhibitors associated with neuropsychiatric events
September 14th 2009In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
Use of broad-spectrum antibiotics during infancy associated with increased risk of pediatric asthma
September 1st 2007Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.
Aspirin may reduce the risk of newly diagnosed adult-onset asthma
February 1st 2007A post-hoc analysis of the large, randomized, double-blind, placebo-controlled Physicians' Health Study found that the use of low-dose aspirin (ASA) on alternating days reduced the risk of adult-onset asthma by a statistically significant 22%.
Salmeterol/fluticasone combination lowers asthma exacerbations
July 1st 2006A salmeterol/fluticasone combination (SFC) surpassed a formoterol/budesonide combination (FBC) in reducing the rate of moderate-to-severe exacerbations in patients with persistent asthma, according to a study published by the journal Respiratory Medicine.
Asthma patient hospitalization risk more than doubles with long-acting beta-agonist use of 3 months
July 1st 2006A meta-analysis of 19 randomized, controlled clinical studies that lasted at least 3 months indicates that long-acting beta-agonists (LABAs) more than double the rates at which asthma patients may become hospitalized.
TELICAST trial of telithromycin produces split results in asthma treatment
July 1st 2006A double-blind, randomized, placebo-controlled study of the ketolide telithromycin administered orally over a 10-day period to 278 asthma patients demonstrated a reduction in asthma symptoms, but did not show a significant treatment effect on patients' morning peak expiratory flow.
Lower oral retinoid dose effective for psoriasis
June 1st 2006A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.
New monoclonal antibody effective for plaque psoriasis
June 1st 2006CNTO 1275, an anti-IL12p40, maintains efficacy in clearing plaque psoriasis for up to 24 weeks after 1 dose, according to results of a phase 2 study presented by researchers at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. The subcutaneously injected agent targets both interleukin 12 and 23, two key cytokines in type 1 immune responses, said study author Gerald G. Krueger, MD, of the department of dermatology, University of Utah Health Sciences Center, in Salt Lake City, Utah.
Levalbuterol no more efficacious than racemic albuterol in treatment of pediatric asthma
November 1st 2005Children suffering from acute exacerbation of asthma can expect levalbuterol (Xopenex, Sepracor) (LEV) to produce results that are no better-yet are more costly-than racemic albuterol (RAC), according to a study published in Pediatric Emergency Care.
Acetaminophen linked to increased rate of newly diagnosed adult-onset asthma
June 1st 2004Acetaminophen use is associated with an increased rate of newly diagnosed adult-onset asthma, according to a study published in the American Journal of Respiratory and Critical Care Medicine. The study findings, from the Nurses Health Study, confirmed and extended the results of similar cross-sectional studies, although the authors stated that it would be premature to recommend the avoidance of acetaminophen for all adults with asthma.
The ocular allergic response: A pharmacotherapeutic review (PDF)
April 1st 2004One of the most common ophthalmic conditions that directs a patient to a primary-care physician or eye-care practitioner is the red, itchy eye. The highest percentage of conjunctivitis is noninfectious or inflammatory, and frequently these cases are allergic in nature. The ophthalmic armamentarium is now filled with a number of pharmaceutical compounds that act specifically at different points along the inflammatory cascade. Formulary decision-making should be based on sound knowledge of the ocular inflammatory cascade and the pathways through which the various ophthalmic antiallergic preparations exert their anti-inflammatory effects.
Efalizumab: A new biologic therapy for the control of chronic plaque psoriasis
January 4th 2004Efalizumab (Raptiva, Genentech/Xoma) is a humanized monoclonal antibody of CD11a that exerts its effect through the blockade of the interaction between leukocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1). FDA recently granted approval for efalizumab in the treatment of chronic moderate-to-severe plaque psoriasis in adults aged 18 years and older. Efalizumab does not achieve clinical response rates equal to cyclosporine or methotrexate, but it lacks the systemic organ toxicities of these agents and is associated with a more rapid onset of action (significant improvements in Psoriasis Area and Severity Index [PASI] response after 2 doses). In addition, efalizumab will likely compete with another approved biologic, alefacept, and off-label use of 2 other biologics currently on the market, etanercept and infliximab. At this time, until further studies comparing efalizumab to other drugs indicated for the treatment of psoriasis are completed and post-marketing surveillance is conducted, the agent?s place on the formulary remains unclear.
The treatment of acute severe asthma in the adult: an overview
September 1st 2003Asthma is a chronic inflammatory disease of the airways affecting 5%–7% of the US and European populations. It accounts for nearly 400,000 hospitalizations and 5,000 deaths per year. Acute asthma comprises those asthmatics with severe symptoms, despite attempts at appropriate control. Typically these patients will present to a local emergency department for evaluation and treatment. This review examines the pharmaceutical treatment options made available to these patients in emergency settings, including their risks, benefits, side effects and overall effectiveness. (Formulary 2003;38:537–543.)