Allergan To Discuss Tazoral Psoriasis Non-Inferiority Study With FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA deems oral tazarotene "not approvable." In addition to a non-inferiority study, Allergan must develop an "acceptable" risk management program and resolve manufacturing problems.
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Allergan will meet with FDA to clarify the design of a Tazoral non-inferiority study in severe psoriasis. Oral tazarotene was deemed "not approvable" by FDA Sept. 24. Despite the FDA action, Allergan will continue to seek a psoriasis indication for Tazoral, the company said. In addition to the need for a non-inferiority trial, FDA gave two other main "non-approvability issues" for Tazoral, Allergan said Sept. 27. The company must resolve manufacturing problems with Tazoral capsules. "Allergan believes this issue is either resolved or will be resolved shortly to FDA's satisfaction," the company said. Allergan must also develop an "acceptable" risk management plan for oral tazarotene, which is a known teratogen. Once FDA reviews Roche's SMART risk management plan for Accutane , Allergan expects to finalize its work on an "appropriate" RMP for Tazoral. Celegene's Thalomid risk management patents could also delay creation of a risk management program for Tazoral (1 (Also see "Celgene In Licensing "Discussions" On Thalomid Risk Management Patents" - Pink Sheet, 22 Jul, 2004.)). On July 12, FDA's Dermatologic & Ophthalmic Drugs and Drug Safety & Risk Management Advisory Committees said that the Tazoral risk management plan was inadequate. The committee voted nine to three, with four abstentions, that Tazoral had not demonstrated a favorable balance of efficacy and risk. The committee also expressed concern about the potential for off-label use of the oral retinoid as an acne therapy (2 ). Allergan submitted the Tazoral NDA Nov. 25, 2003, giving it an estimated action date of Sept. 25. - Andrew Kasper |