UPDATE: FDA Panel Backs Proposed Glaxo, Valeant Epilepsy Drug
12 8월 2010 - 4:22AM
Dow Jones News
A Food and Drug Administration panel Wednesday backed a proposed
epilepsy drug called Potiga developed by Valeant Pharmaceuticals
International (VRX) and GlaxoSmithKline PLC (GSK, GSK.LN).
The panel unanimously said the companies provided data showing
the product was effective as an add-on treatment in certain
epilepsy patients. The panel also said it believed patients could
be monitored for urinary side effects, which the FDA said is the
main safety concern with the product.
Specifically, 11 members of the panel said urinary retention
could by "mitigated by patient monitoring" while two people
abstained from voting on that question.
Potiga, also known by its generic name ezogabine, is being
reviewed Wednesday by the FDA's Peripheral and Central Nervous
System Drugs Advisory Committee. The positive votes on its
effectiveness and safety amount to a recommendation that the FDA
approved the product. The FDA usually follows the advice of its
panels of non-FDA medical experts but is not required to.
In a statement, Atul Pande, a GlaxoSmithKline senior vice
president, said the company is "encouraged by the advisory
committee's assessment of ezogabine" and awaits a decision by the
FDA.
Potiga is designed to treat adults with partial onset seizures
who aren't adequately treated with other medications. Potiga would
be added to other medications.
Epilepsy is a brain disorder, often marked by seizures, in which
clusters of nerve cells, or neurons, in the brain sometimes signal
abnormally. The condition affects about 3 million people in the
U.S.
Valeant is being acquired by Canadian pharmaceutical firm
Biovail Corp. (BVF) in a deal that's expected to close by the end
of the year.
In a briefing memo prepared for the meeting, the FDA said three
clinical trials looking at different doses of Potiga showed it
helped reduce the number of seizures in patients compared with
those who weren't receiving the drug when given three times a day.
The FDA said most cases of urinary retention seen in clinical
studies were reversible. Other side effects seen with Potiga
included dizziness and fatigue.
Officials representing Valeant told the panel that about
one-third of epilepsy patients are not adequately treated with
current medications and that many of those patients could benefit
from the addition of Potiga. They said Potiga's side effects could
be managed and noted that various side effects are seen with the
other 17 antiepileptic drugs on the market.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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