Allergan's Psoriasis Drug Tazoral Rejected By FDA, Benefits Do Not Outweigh Risks

Main Category: Eczema / Psoriasis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Jul 2004 - 16:00 PDT

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Allergan Inc suffered a set back when the FDA (USA) rejected their drug Tazoral, for psoriasis. The panel said that the risks outweighed the benefits. Risks included birth defects and weakened bones. The panel suggested more long-term trials be carried out with more female patients. Allergan's share price dropped as a result, from $86.70 to$76.40.

The panel's vote was not unanimous. The vote went 9 against and 3 in favour of the drug.

Allergan was sure it will be able to address the panel's recommendations.

The panel has an advisory capacity, the decision is the FDA's. However, it is unusual for the FDA to go against the advice of the panel.

Tazoral is a drug designed to treat the scaly bumps and flaky skin of moderate to severe psoriasis. It is the capsule version of tazarotene, a retinoid (retinoids are known to cause birth defects).

The panellists said that Allergan's assurance that it would set up a program to help warn women of possible infant risk and have compulsory negative pregnancy tests for all users was not enough.

The panel said that there were not enough patients in the study. In two of the main studies only one fifth of the patients experienced any improvement while one tenth experienced bone density loss.

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