GLG News by Allergists (US)

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

Will Merck's New Asthma Drug Make the Big Time?

July 6, 2010

Analysis of:FDA Approves Merck's DULERA® Inhalation Aerosol | www.reuters.com

The FDA recently approved Merck's Dulera, inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination, for moderate to severe asthma control. This agent is the third combo inhaler, after Advair and Symbicort; thus it starts with an immediate disadvantage in the market. Furthermore, timing seems most inauspicious in light of the FDA's current phobia with the entire class of LABA agents. Any potential profits may be negated by the expense of conducting mandatory long-term safety trials.

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

Qforma's Online Database: Exposing Pharma's Physician Marketers?

May 15, 2009

Analysis of:In patients' hunt for care, doctor database 'a place to start' | www.usatoday.com

undefinedundefined undefined If the Qfarma database makes public those physicians with significant financial conflicts of interest, will this lead to more intense regulatory  scrutiny of these physicians?  Does this online database place at risk the industry practices?

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

LABA daba done?

December 11, 2008

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

Some information of note, the current FDA briefing document (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-00-index.htm) is a publication entirely created by GSK,  Novartis, and AstraZeneca and not an independently created FDA review.  It merely is a summary of trials data already published; in as much, there may be other unpublished data by these pharma co's that may be relevant but will not be part of the debate.  Absent from the FDA document are the FDA reviewer's comments..?redacted.  Furthermore, none of the individual SAE reports are included for review and analysis; we are again left only with pharma's version and clinical trials interpretation. 

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.

Mitchell BoxerAssistant Clinical ProfessorAlbert Einstein College of Medicine

Another nasal corticosteroid

August 30, 2007

Analysis of:Collegium Pharmaceutical provides update on development of its nasal inhaled steroid for allergic rhinitis | www.pipelinereview.com

A new nasal corticosteroid being released by another pharmaceutical company

Mitchell BoxerAssistant Clinical ProfessorAlbert Einstein College of Medicine

Xyzal approval

August 30, 2007

Analysis of:New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com

Zyrtec will soon be available over the counter and this new product will attempt to keep the antihistamine market share for Sanofi-Aventis - although Zyrtec is presently manufactured by Pfizer.  The antihistamine market is quite large and the OTC versus prescription situation is making this problematic for both physicians, patients and insurance companies.

David MandelPhysicianDAVID R MANDEL MD

dupuytrens contracture

August 7, 2007

Analysis of:The Journal of Hand Surgery Publishes Initial Phase III Data on Xiaflex (formerly known as AA4500), Auxilium's Investigational Treatment for Patients with Dupuytren's Contracture | pharmalive.com

I am a rheumatologist and treat many pts with this  condition conservativelywewill be partcipating in an upcoming clin.trial with their injectable compound that has some very unique properties to relieve the contractures and possible avoid surgery

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.

Mitchell BoxerAssistant Clinical ProfessorAlbert Einstein College of Medicine

intranasal antibiotics for chronic sinusitis

April 23, 2007

Analysis of:FDA Approves Fast Track Designation for Naryx Pharma’s Product for Chronic Sinusitis | www.naryxpharma.com

I have not found nebulized antibiotic therapy to be of great success in patients with chronic sinusitis.  There are already a few pharmacies that have formulated an array of nebulized antibiotics and I have tried them in a few patients with no success.   

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