[Today’s action in psoriasis does not automatically doom oral Tazarotene as a treatment for wet AMD, but it does perhaps lengthen the odds a little. Patients old enough to have AMD presumably would not be pregnant, but that in itself doesn’t imply that a drug of this class would be safe.
Including the drop in after-hours trading, Allergan fell about 10% today.]
>> BOSTON (CBS.MW) - An advisory committee of the U.S. Food and Drug Administration has recommended that the agency not approve Allergan's oral medication for psoriasis, Tazoral.
The committee's decision was issued late Monday afternoon, following a scheduled hearing by the FDA to review safety and efficacy data for the drug. While not a final rejection, the FDA generally always rules in accordance with the recommendations of its expert advisory panels.
Allergan (AGN: news, chart, profile) had filed for approval for the use of Tazoral to treat moderate to severe psoriasis.
Tazoral, an orally administered formulation of tazarotene, belongs to a class of drugs based on Vitamin A derivatives called retinoids, which have been linked to severe birth defects. Much of the FDA advisory panel's ruling covered issues relating to fetal damage risks. The acne drug Accutane is also derived from retinoids. Among female patients, that drug can only be prescribed to those who agree to take a test to prove they are not pregnant.
Allergan already markets a topical version of tazarotene called Tazorac. The FDA will hold a formal vote on whether to approve Tazoral at a later date.
Allergan officials were not immediately available for comment. <<
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