d******8
发帖数: 1972 | | d******8
发帖数: 1972 | 2 WASHINGTON, D.C. (TheStreet) --Chelsea Therapeutics(CHTP_) faces a big
challenge Thursday -- convincing a panel of outside experts to look
favorably on its hypotension drug Northera despite a damning FDA review that
recommended against the drug's approval.
"On the basis of the safety concerns, compounded by absence of evidence of
durability of effect, my regulatory recommendation is that we should not
grant approval for droxidopa at this time," concluded FDA reviewer Melanie
Blank in an FDA briefing document released Tuesday. [Droxidopa is the
generic name for Northera.]
Chelsea is seeking approval for Northera as a treatment for neurogenic
orthostatic hypotension (NOH) -- a rare condition in which blood pressure
drops dangerously low upon standing. The condition often strikes people who
suffer from Parkinson's disease.
The FDA has convened a panel of experts who are meeting today to review the
Northera clinical data. At the end of the meeting, the experts will vote on
whether to not to recommend Northera's approval. The FDA will make a final
approval decision on March 28.
Chelsea conducted a single clinical trial demonstrating "strong evidence"
that Northera benefits NOH patients for at least one week, the FDA review
states. However, FDA's reviewer said Northera's beneficial effect did not
last long enough for patients, particularly in light of safety concerns,
including 18 deaths that may or may not be tied to the drug.
Droxidopa is already approved in Japan for the treatment of NOH but FDA's
review mentions nine reported cases of neuroleptic malignant syndrome (NMS),
an often-fatal condition causing fever and rigid muscles tied to the drug's
use.
For Chelsea to receive a positive vote Thursday, it will have to convince
the expert panel that the endpoints and duration of the clinical trials used
to assess Northera's clinical benefit were sufficient. Chelsea and FDA
reached agreement in advance on these trial designs. Chelsea must also
explain the patient deaths in the trial and show why Northera was not the
cause.
Chelsea shares closed Wednesday trading at $2.41 and will be halted Thursday
for the FDA panel. The stock has lost more than half its value since Feb.
13 when the company first disclosed the FDA's serious concerns about
Northera.
--Written by Adam Feuerstein in Boston.
>To contact the writer of this article, click here: Adam Feuerstein. | d******8
发帖数: 1972 | | N**********p
发帖数: 408 | 4 要是通过了，马上挂单买， 2.66也要
【在 d******8 的大作中提到】
: 马上投票
| N**********p
发帖数: 408 | | d******8
发帖数: 1972 | | d******8
发帖数: 1972 | 7 Feb 23 (Reuters) - Chelsea Therapeutics International Ltd's hypotension drug
Northera should be approved for use in the United States, a committee of
independent experts recommended on Thursday.
The panel assembled by the Food and Drug Administration voted 7-4 for
approval of the drug known generically as droxidopa, despite government
warnings about whether the treatment is safe and effective for treating
chronic illness. One committee member abstained and another did not cast a
vote. | N**********p
发帖数: 408 | 8 其实就是说还没通过，28号决议。但是盘后已经开始飙了。。。
drug
【在 d******8 的大作中提到】
: Feb 23 (Reuters) - Chelsea Therapeutics International Ltd's hypotension drug
: Northera should be approved for use in the United States, a committee of
: independent experts recommended on Thursday.
: The panel assembled by the Food and Drug Administration voted 7-4 for
: approval of the drug known generically as droxidopa, despite government
: warnings about whether the treatment is safe and effective for treating
: chronic illness. One committee member abstained and another did not cast a
: vote.
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