GLG News by Pediatricians (US)

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

FDA Poised to Damage Asthma Pharmacotherapy Advances

December 10, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

The use of long-acting beta-agonists (LABAs) in the treatment of persistent asthma has become one of the most controversial issues of respiratory disease management during this decade. Both salmeterol and formoterol have been shown in numerous clinical trials of asthma to dramatically improve pulmonary function, symptoms scores, and need for rescue medication. However, some long-term safety studies have demonstrated increased risk of severe asthma exacerbations when these LABAs are used as monotherapy without concomitant inhaled steroid therapy. Based on this data, the FDA is considering the withdrawal of LABAs from the US market. I anticipate the FDA will come to their senses and appreciate the significant benefit that combination LABA/ICS therapy has in the vast majority of moderate and severe asthmatics for whom they are appropriately prescribed. In my opinion, cessation of LABA therapy for asthma would return us to asthma mortality rates not seen since the 1990s.     

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Will Xolair Become Obsolete in the Treatment of Allergies?

June 10, 2008

Analysis of:Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com

This recent report characterizes a newly discovered anti-IgE monoclonal antibody (mAb12) which appears dramatically more potent than omalizumab (Xolair) in its ability to reduce systemic IgE levels. If further studies confirm this enhanced reduction of IgE and IgE-bearing cells, mAb12 has significant potential to replace omalizumab as effective anti-IgE therapy with just one dose, even in patients with very high initial levels of total IgE. The potential market share for such a treatment is enormous since at least 25% of the population suffers from Ige-mediated diseases such as allergic rhinitis, asthma, atopic eczema, and food allergy.

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Impact of Symbicort on the U.S. Asthma Market

June 11, 2007

Analysis of:AstraZeneca Launches New Advance In Asthma Treatment - Symbicort Maintenance And Reliever Therapy (Symbicort SMART) | www.medicalnewstoday.com

Symbicort is AstraZeneca's answer to Advair, presently the number one combination ICS/LABA in the U.S. for treating moderate to severe asthma. Symbicort will not, however, have an indication for quick relief of bronchospasm as it does in many European countries. Nevertheless, Symbicort appears to be very well positioned to achieve significant market share, especially with the imminent release of the revised NIH guidelines which strongly emphasize long-term control of asthma.

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Of Mice and Men: Revisiting the Hygiene Hypothesis

June 23, 2006

Analysis of:Wild Vs. Lab Rodent Comparison Supports Hygiene Hypothesis | medicalnewstoday.com

The "Hygiene Hypothesis" has gained recent favor to explain the dramatic increase in allergic conditions, as well as autoimmune disorders, especially in more industrialized countries that emphasize sanitation and stringent public health measures. The theory rests on lack of sufficient immunologic stimulation due to overly hygienic lifestyle thus encouraging allergic and possibly autoimmune processes to predominate. This hypothesis is supported by a recent study from Duke University comparing laboratory rodents living in an essentially "germ-free" environment to wild rodents naturally exposed to bacteria and parasites. The wild mice and rats have higher levels of certain antibodies which appear to afford protection from allergic and autoimmune disease. This putative mechanism may offer insight into the pathogenesis of allergy and autoimmunity in humans which could then be applied to developing preventive therapies to reduce the frequency of these chronic, debilitating disorders.

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Is Roflumilast Blockbuster Therapy or a Ho-Hum Me-Too Drug?

June 16, 2006

Analysis of:Roflumilast Effective for Treating Mild-to-Moderate Asthma | www.medscape.com

Roflumilast is safe and effective in treating patients with mild-to-moderate asthma, according to a report in the May issue of the Annals of Allergy, Asthma, & Immunology. Altana and Pfizer are co-developing the experimental drug which is an oral phosphodiesterase type 4 (PDE-4) inhibitor with demonstrated anti-inflammatory and brochodilator activity and pharmacokinetics that allow once-daily dosing. Based on its mechanism of action, roflumilast can be expected to have similar efficacy to theophylline products but a more favorable side effect profile. Although current expert asthma guidelines continue to mention theophylline as second-line therapy, its relative market share has fallen dramatically over the last two decades with the present emphasis on inhaled corticosteroids and leukotriene modifiers. Assuming eventual European and FDA approval, roflumilast has potential to make a significant impact on the respiratory marketplace. How much depends greatly on marketing strategy by Altana and Pfizer as well as possible demonstration of superiority in future clinical trials. 

 

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Another Blow to Sanofi-Aventis' Market Share

June 13, 2006

Analysis of:Sanofi Suspends Ketek Clinical Trial Enrollment | www.medscape.com

Ketek (telithromycin) is indicated for treating bacterial infection of the upper and lower respiratory tract in patients 18 years and older. Pediatric trials have been ongoing for almost one year to evaluate efficacy in otitis media (ear infection) and tonsillophayngitis (strep throat). Reports of 3 cases of liver toxicity in adults resulted in a public health advisory issued by the FDA on January 23, 2006. Now Sanofi-Aventis has suspended further enrollment of children into these international clinical studies pending further discussions with the FDA and European regulatory authorities. The possible loss of pediatric indications, or even restriction due to cautionary warnings, would likely further curtail physician usage of this once promising antibiotic.  

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

The LABA Controversy Continues

June 8, 2006

Analysis of:Long-Acting ß-Agonists May Increase the Risk for Death from Asthma | www.medscape.com

In November 2005 the FDA approved labeling changes for asthma inhalers containing long-acting beta-agonists (LABAs) warning that there may be an increased risk of asthma-related severe exacerbation or death from use of these products. A meta-analysis of this effect will be published in the 20 June 2006 issue of Annals of Internal Medicine. The authors conclude from their review that both salmeterol and formoterol usage increases risk for hospitalization, life-threatening asthma exacerbation, and asthma-related death. Although the number of reported events overall is low, this data has potential major implications for the prescribing and acceptance of LABAs in asthma pharmacotherapy around the world.

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Treating Severe Asthma with Ciclesonide: Is the New Kid on the Block Better?

June 1, 2006

Analysis of:Inhaled Ciclesonide May Reduce Need for Oral Steroids in Persistent Asthma | www.medscape.com

Severe, steroid-dependent asthma remains a frustrating and expensive condition despite numerous pharmaceutical agents recently developed for therapy. Newer, more potent topical inhaled corticosteroids are considered by most asthma specialists to be the cornerstone of therapy for all levels of severity. Ciclesonide, co-developed by Sanofi-Aventis US and Altana Pharma AG, is a "soft steroid" which requires local esterification to its active metabolite. This feature may give ciclesonide a superior benefit/risk ratio, especially at higher dosing required for severe asthmatics. An international study of ciclesonide's ability to reduce the need for oral steroids in severe asthma has been published recently in Chest. This trial complements existing data showing significant efficacy with minimal local and systemic side effects during ciclesonide treatment.  

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Allergy Drops: Not Quite Ready for Prime Time

May 26, 2006

Analysis of:Sublingual Immunotherapy: A Comprehensive Review | www.medscape.com

Allergic rhinitis affects at least 20% of people worldwide and there is a higher prevalence in children and certain regions of North America. Although nobody dies of a runny nose, the morbidity and health care costs of this chronic condition are enormous. Desensitizing allergy shots (immunotherapy) are the only disease-modifying treatment  currently approved in the US. Subcutaneous immunotherapy has limitations of patient acceptability and a low, but concerning, rate of systemic reaction. Sublingual immunotherapy (SLIT) has been developed and studied in Europe as a potentially safer and simpler way to administer allergenic extract. A recent review in the JACI delineates numerous issues which must be addressed with SLIT before its acceptance by American allergists.

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Thumbs Down on Non-prescription Nasal Steroids

May 22, 2006

Analysis of:Joint Task Force Says No to OTC Intranasal Corticosteroids | www.medscape.com

Intranasal corticosteroids (INS) have been used for over 20 years in the treatment of allergic rhinitis (AR), both seasonal and perennial. Numerous studies show they are the the single most effective therapy for all nasal allergy symptoms, including itching, sneezing, congestion and drainage. Given the increasing prevalence and severity of AR in American patients and the enormous associated healthcare costs, non-prescription medications have a huge financial market potential in this frustrating, chronic condition.

A Joint Task Force of the two major professional associations of board-certified allergists has recently published a position statement warning of the dangers of over-the-counter access to intranasal corticosteroids. The Joint Task Force urges the Food and Drug Administration not to approve over-the-counter access to intranasal corticosteroids. If followed, this recommendation not to pursue non-prescription status for INS may have far reaching implications on the AR pharmaceutical market in several ways.

Page : 12Next1 to 10 of 15