you very much for your question.
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.
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.
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.
(riluzole) was approved by FDA on December 1995 for amyotrophic lateral
sclerosis. It was the first drug to be approved for ALS.
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.
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.
to Meucci N, Nobile-Orazio E, and Scarlato G., Institute of Clinical
Neurology, University of Milan, Italy, in 1996:
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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