Bio-Technology General Corp. (BTG) has voluntarily withdrawnits new drug application for Hepandrin (oxandrolone) fortreating alcoholic hepatitis. The Iselin, N.J., company announcedFriday that it decided to pull the NDA, which it submitted inJanuary, after FDA said the two studies in the application werenot sufficient for approval of the drug.
The studies of the steroid oxandrolone, a testosterone analog,were conducted independently by the Department of VeteransAffairs. Oxandrolone is exclusively licensed to BTG from G.D.Searle & Co. BTG obtained rights to the drug from GynexPharmaceuticals Inc. when the companies merged last August.
BTG apparently has not decided whether to pursue furthertrials for the alcoholic hepatitis indication. "Based on furtherdiscussions with the FDA and experts on alcoholic liver disease,we will determine what course to take in our development ofoxandrolone for alcoholic hepatitis," said Sim Fass, BTG'spresident and chief executive officer.
The company said it will continue to develop the drug for otherindications under the trade name Oxandrin. It has completed aPhase III trial of oxandrolone in constitutional delay of growthand puberty and is conducting a Phase III trial for use inTurner's syndrome and two Phase II trials for the treatment ofHIV-associated wasting. Oxandrin has been granted orphanstatus for all these indications.
In January, Oxandrin was approved in Australia for treatmentof pediatric growth disorders (see BioWorld, Jan. 18). It will bemarketed there under the brand name Lonavar.
BTG's stock (NASDAQ:BTGC) was down 13 cents a share onFriday, closing at $5.
-- Brenda Sandburg News Editor
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