n*******n
发帖数: 540 | 1 富马酸二甲酯，
这么简单的药物，当初怎么发现的？
专利没有问题吗 | p****u
发帖数: 239 | 2 Dimethyl fumarate has won FDA approval to treat relapsing-remitting forms of
multiple sclerosis and will be sold under the name Tecfidera, the agency
said Wednesday.
Manufactured by Biogen Idec, the drug is also known as BG-12. It becomes the
third oral disease-modifying medication available to treat MS. Others
include fingolimod (Gilenya) and teriflunomide (Aubagio).
Dimethyl fumarate has a novel mechanism of action relative to existing MS
drugs. It is believed to activate the nuclear factor-like 2 transcriptional
pathway, thereby reducing oxidative stress that contributes strongly to
demyelination.
The drug has also been used for many years in Europe and elsewhere to treat
psoriasis, and has also been used as a fungicide and desiccant in furniture
manufacture.
Two placebo-controlled phase III trials served as the basis for approval,
the agency said. Called DEFINE and CONFIRM, they enrolled a total of some 2,
700 patients. In addition to comparing the drug with placebo, CONFIRM
included a third arm with open-label glatiramer acetate (Copaxone), a
standard injectable MS drug.
Both trials demonstrated that dimethyl fumarate was superior to placebo in
preventing relapses and delaying disability progression. It also appeared to
be somewhat more effective than glatiramer acetate in CONFIRM.
The most common adverse effects were gastrointestinal complaints and
flushing. The FDA also noted that the drug carries a risk of lymphocytopenia
, although infections did not appear to be increased as a result in the
phase III studies.
"No drug provides a cure for multiple sclerosis so it is important to have a
variety of treatment options available for patients," said Russell Katz, MD
, director of the Division of Neurology Products in the FDA's Center for
Drug Evaluation and Research, in a statement announcing the approval.
A Biogen competitor, Teva Pharmaceuticals, had petitioned the FDA to hold an
advisory committee meeting on the drug before approving it, citing the
hematologic effects and other risks, but the agency declined to do so.
http://www.medpagetoday.com/Neurology/MultipleSclerosis/38122?i |
|
