Hoffmann-La Roche Inc. has filed a new drug application forddC that includes information on its safety and efficacy inAIDS when used alone and in combination with AZT.

"We feel we have enough information to justify filing for thetwo indications," company spokesman Paul Oestreicher toldBioWorld. He declined to provide specific data on how well thedrug did in the clinic.

Although he could not estimate when approval might bereceived, Oestreicher said that "we've been informed thiswould have high-priority review at the FDA."

The Nutley, N.J., company has not yet set a price on thecompound, which will compete with Burroughs Wellcome's AZT,a reverse transcriptase inhibitor, as well as with the recentlyapproved Bristol Myers Squibb Co. nucleoside, ddI.

Clinical data have shown that a combination of inhibitors mayavoid the resistance that can develop with therapy using eachof the drugs alone.

Roche is seeking approval for a combination therapy that woulduse the same dose of both drugs that are currently used foreach alone, Oestreicher said.

He said a head-to-head comparison of ddC and ddI is nowunderway. -- Roberta Friedman, Ph.D.

(c) 1997 American Health Consultants. All rights reserved.