GLG News by Immunologists (US)

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.

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.   

Mitchell BoxerAssistant Clinical ProfessorAlbert Einstein College of Medicine

Xolair apprehension

February 27, 2007

Analysis of:FDA Orders Black Box Anaphylaxis Warning for Omalizumab (Xolair) | www.medpagetoday.com

There is a concern about anaphylaxis secondary to Xolair administration and this may result in longer waiting times after the administration of the drug.

Mitchell BoxerAssistant Clinical ProfessorAlbert Einstein College of Medicine

Evaluation of Change therapy

February 13, 2007

Analysis of:Patient Treatment Completed in Phase 3 Trial of C1-Esterase Inhibitor in Hereditary Angioedema | www.ptcommunity.com

HAE is a rare but potentially life threatening immunologic disease.  If c1 esterase inhibitor is found to be effective in preventing exacerbations of HAE than this novel treatment will have a great impact on the lives of those affected and will undoubtedly replace the present treatments such as androgens in preventing attacks.  It would be of interest in seeing how the European community is presently using this replacement therapy.

Michael BlaissPartnerALLERGY & ASTHMA CARE

It's Hot: A New Treatment for Asthma

April 26, 2006

Analysis of:Bronchial Thermoplasty for Asthma | ajrccm.atsjournals.org

Bronchial thermoplasty (BT) reduces the potential for smooth muscle–mediated bronchoconstriction by reducing the mass of smooth muscle in the walls of conducting airways.

This study showed clinical improvement over 12 weeks in a small group of mild to moderate asthma patients. Also the authors showed improvement in bronchial hyperreactivity over 2 years which suggests continued clinical improvement or stability of the patient's asthma. No significant side effects were seen.

Asthmatx is the developer of this technique. A major study is on going for FDA approval which the company states should be published in 2008 . It is probably worth looking at as a future player in asthma care.

Michael BlaissPartnerALLERGY & ASTHMA CARE

Antibiotics for Asthma?

April 17, 2006

Analysis of:The Effect of Telithromycin in Acute Exacerbations of Asthma | content.nejm.org

This study assessed adults with an acute exacerbation of their asthma to determine if 10 days of oral treatment with telithromycin (Ketek) (at a dose of 800 mg daily) in addition to usual care lead to faster and more efficacious relief of their asthma.  This double blind trial showed improvement on one primary efficacy end point: change from baseline over the treatment period in symptoms (as recorded by patients in a diary card) but not in the peak expiratory flow in the morning at home. Although 61 percent of patients had evidence of infection with C. pneumoniae, M. pneumoniae, or both, there was no relationship between bacteriologic status and the response to asthma treatment.

Michael BlaissPartnerALLERGY & ASTHMA CARE

Do Long-Acting Beta Agonists Kill Asthma Patients?

April 7, 2006

Analysis of:Trouble Breathing | www.forbes.com

This article published in Forbes and the interview on the Today Show on 4/6/06 discussed the possible adverse reactions and death associated with the use of salmeterol, a long-acting beta agonist for asthma, used alone and in combination with fluticasone, an inhaled corticosteroid, under the trade name of Advair in the United States. With the new stricter indication and black box warning with salmeterol by the FDA this year and the recent press about the possibility of increased risk of death in asthma patients using this agent, there will probably be a decrease of use of this agent as a first-line medication in asthma especially in the primary care arena.

Michael BlaissPartnerALLERGY & ASTHMA CARE

Etanercept for Severe Asthma?

April 6, 2006

Analysis of:Evidence of a role of tumor necrosis factor alpha in refractory asthma | content.nejm.org

Severe refractory asthmatics are the highest cost asthma patients for  managed care due to increased emergency department visits and hospitalizations. This preliminary study suggests that soluble TNF-- <!--[if !vml]--><!--[endif]--> receptor etanercept (25 mg twice weekly) in the patients with refractory asthma leads to improve in several aspects of asthma control. Therefore this agent may have a role in management of severe asthma.

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