UPDATE:FDA Panel Votes Against Approval Of Forest Lung Drug Daxas
April 07 2010 - 5:19PM
Dow Jones News
A Food and Drug Administration panel Wednesday voted against
approval of a proposed new type of lung drug from Forest
Laboratories Inc. (FRX).
The panel voted 5 to 10 against a question that asked if the
data submitted by Forest provided "substantial evidence" to support
approval of the product, known as Daxas, to treat certain patients
with chronic obstructive pulmonary disease, or COPD
The decision came after two positive previous votes on Daxas,
also known by its generic name, roflumilast, on safety and
effectiveness. The panel voted 9 to 6 on each vote that Daxas was
effective and safe. The FDA usually follows the advice of its
panels but isn't required to do so.
However, some panel members said more information is needed
about how Daxas compares to other treatments for COPD before the
product is approved.
Lawrence Olanoff, Forest's chief operating officer, said the
final vote was "disappointing" but that he believed the door was
still open for approval given the positive votes on safety and
effectiveness. He said the company would discuss labeling of the
product as well as a risk mitigation plan with the FDA.
Another company, Nycomed, submitted the Daxas application to the
FDA last July, but the application was transferred to Forest in
December. Forest amended the application and proposed a narrower
indication for the product as well as a warning regarding
neuropsychiatric events.
In a review of the product, the FDA said the effectiveness of
Daxas appeared to be "quite modest." The agency also said there
were psychiatric side effects seen in clinical studies of the drug,
along with gastrointestinal side effects such as diarrhea and
nausea. The FDA also raised concerns about weight loss seen in some
patients taking Daxas.
"Of significant concern are the occurrence of three completed
suicides and two suicide attempts" among patients receiving Daxas
compared with no suicides or attempts in the placebo group, the FDA
said.
The agency said that while clinical studies looking at Daxas
showed there was a statistically significant improvement in a
measure of lung function compared with groups of patients not
taking the drug, "the differences between the groups in mean change
from baseline were quite modest."
The product is designed to treat COPD, which is a group of lung
conditions such as emphysema and chronic bronchitis that cause a
narrowing of airways in the lungs, making it difficult to breathe.
COPD is the fourth-leading cause of death in the U.S.
Daxas, a tablet that would be taken once daily, works by
inhibiting an enzyme called phosphodiesterase 4, which is believed
to play a role in the inflammatory process involved with airway
constriction. It would fall into a category of drugs known as PDE-4
inhibitors.
So far, companies have struggled to develop PDE-4 inhibitor
products. In 2003, an FDA panel voted against approval of a similar
drug, cilomilast, which was being developed by GlaxoSmithKline PLC
(GSK).
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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