The FDA sent a product license application (PLA) "actionletter" on Thursday to Univax Biologics Inc., and itscollaborator, Rh Pharmaceuticals Inc.The letter requested additional background information oncompleted clinical trials and on manufacturing issues forWinRho SD, a drug for the treatment of ImmuneThrombocytopenic Purpura (ITP) and prevention of Rhisoimmunization."The FDA raised no clinical issues that were not discussedin detail at the March 24, 1994 meeting of the FDA BloodProducts Advisory Committee," Scott Harkonen, vicepresident of medical and regulatory affairs at Univax, saidin a prepared statement. "As a result, almost all of theadditional information the FDA has asked for wasanticipated and has already been prepared for submission."Univax, of Rockville, Md., licensed WinRho SD fromWinnipeg, Canada-based Rh Pharmaceuticals, whichmarkets the drug there for prevention of Rhisoimmunization in pregnant women. The PLA andEstablishment License Application (ELA) for WinRho SDwere filed simultaneously in June 1993. ITP affectsapproximately 100,000 Americans each year, primarilypeople with HIV/AIDS.According to Montgomery Securities analyst BrandonFradd, the FDA action is positive news for Univax since itsuggests that no serious deficiencies were found in theWinRho SD PLA data. "There would have been a problemif the FDA had asked for additional clinical trial data, butthis letter contains no request for new studies," Fradd said.Fradd predicted that WinRho SD could gain FDA approvalin "the next several months" and said it's possible thecompany's stock will rise once the market digests the news.The company announced the FDA letter after the marketclosed on Thursday. Univax stock (NASDAQ:UNVX)closed Thursday at $5.63, up 25 cents per share.The company plans to discuss the FDA letter in more detailduring a conference call with journalists today. n
-- Lisa Piercey Washington Editor
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