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Question (10/23/2013):

Title: Is IVIG (Intravenous Immunobglobulin) a FDA approved treatment for slowing the progression of ALS (Amyotrophic Lateral Sclerosis)?.

Can you tell me if IGg immuno-globulins IVIG, Intravenous immunoglobulin, are FDA approved treatment for slowing the progression of ALS, Amyotrophic Lateral Sclerosis?

Answer:

Thank you very much for your question.

The United States Food & Drug Administration (FDA) granted Orphan Drug status to Cogane™ (PYM50028) for the treatment of amyotrophic lateral sclerosis (ALS) in July 28th, 2011.

FDA allowed, in July 1st, 2009, patients with Amyotrophic Lateral Sclerosis to have access to a drug called Iplex under an Investigational New Drug (IND) application. Iplex (mecasermin rinfabate [rDNA origin] injection), is a combination of two substances: human insulin-like growth factor 1 (IGF-1) and human insulin-like growth factor-binding protein-3 (rhIGFBP-3). Iplex is approved by the FDA only for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

The U.S. Food and Drug Administration (FDA) approved Nuedexta for "pseudobulbar affect" (PBA), a neurologic condition that sometimes occurs in people with amyotrophic lateral sclerosis (ALS) and involves episodes of involuntary emotional expression out of proportion to or distinct from the person's actual emotional state. The approval was announced by Nuedexta's developer, Avanir Pharmaceuticals, on Oct. 29, 2010.

Rilutek (riluzole) was approved by FDA on December 1995 for amyotrophic lateral sclerosis. It was the first drug to be approved for ALS.

Dr. Robert H. Brown Jr., a leading ALS researcher at Massachusetts General Hospital whose work helped discover the ALS gene, recommended to O'Leary, 44, to try regular infusions of intravenous immunobglobulin, IVIG, a type of protein found in human blood that helps to fight off harmful bacteria, viruses and germs. IVIG is not effective for most patients, but it worked for O'Leary.

In 1993 Ostermeyer-Shoaib and B, Patten BM., Department of Neurology, Baylor College of Medicine, Houston, Texas 77030., found a IgG subclass deficiency in amyotrophic lateral sclerosis. Their findings suggested a defect in the IgG subclass expression in ALS.

Acording to Meucci N, Nobile-Orazio E, and Scarlato G., Institute of Clinical Neurology, University of Milan, Italy, in 1996:

Seven consecutive patients with amyotrophic lateral sclerosis (ALS) were treated with intravenous immunoglobulins (IVIg; 0.4 g/kg per day for 5 consecutive days followed by monthly 2-day infusions at the same daily dosage) continued with oral cyclophosphamide (1-2 mg/kg per day), for 4-13 months (mean 8.1). Response to treatment was assessed by means of the Medical Research Council (MRC) rating scale for muscle strength on 40 muscles (10 per limb), a clinical scale for bulbar function and a modified Rankin disability scale. All patients continued to deteriorate during treatment on as regards both their MRC score and either their bulbar or Rankin score or both. The progression of the disease during treatment, expressed as the monthly variation in MRC score (mean = -2.71; SD = 1.36), was no slower than that estimated before therapy (mean = -1.81; SD = 0.93). Even if the results of this small, uncontrolled study do not permit the exclusion of an effect of IVIg on the progression of ALS, they also do not provide any evidence that this expensive form of therapy consistently slows the course of the disease.



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