Reuters logo
UPDATE 1-FDA to review Avanir's Zenvia application in 6 months
May 17, 2010 / 1:24 PM / 7 years ago

UPDATE 1-FDA to review Avanir's Zenvia application in 6 months

* FDA sets Oct. 30 as action date for Zenvia review

* Avanir shares up 6 pct in pre-mkt trade

May 17 (Reuters) - Avanir Pharmaceuticals Inc AVNR.O said the U.S. health regulator accepted the resubmission on its experimental treatment for a neurologic condition and will review the application within six months.

The U.S. Food and Drug Administration set an action date of Oct. 30 on the drug Zenvia, the company said in a statement.

Zenvia aims to treat pseudobulbar affect (PBA), a neurologic condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying in patients with certain underlying neurologic diseases or injuries.

PBA affects an estimated two million Americans with multiple sclerosis, Lou Gehrig’s disease, stroke and other neurological diseases or trauma that can cause brain lesions.

The company had faced a setback on the drug in October 2006 when the FDA sent it a so-called approvable letter and asked for additional trial data.

Avanir expects an FDA approval decision in the fourth quarter of 2010.

Shares of the company were up 6 percent to $2.85 in pre-market trade. They closed at $2.69 Friday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Prem Udayabhanu)

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below