Panel Rejects Allergan Drug

A Food and Drug Administration advisory panel on Monday rejected Allergan Inc.’s oral psoriasis drug Tazoral because it could cause birth defects when used by pregnant women.

Allergan’s shares slid nearly 4% after the panel’s 9-3 vote and continued to tumble in after-hours trading.

Tazoral is aimed at people with moderate to severe psoriasis, but panelists worried that the drug would be prescribed to treat acne, a much more common condition affecting teens and young adults. The acne medication Accutane is in the same chemical class as Tazoral and has been linked to birth defects in 160 children.

The panel was concerned even though Allergan pledged to track all physicians, pharmacies and women prescribing, dispensing and using the drug. Robert Stern, a dermatologist at New York’s Beth Israel Hospital, said the benefits of Tazoral were too small to justify the risks associated with the drug.

Stern, chairman of the FDA panel, said patients on Tazoral didn’t do as well as patients he has treated with ultraviolet light, a standard psoriasis therapy. “They showed us their best photographs,” Stern said of Allergan. If his patients looked the same after ultraviolet treatment, Stern said, “I’d wonder if my lights were up to full power.”

Panelists had other concerns, including inconclusive data linking Tazoral to loss of bone density in patients. Several panelists said the risk of fractures in patients on Tazoral needed additional study.

The vote was a blow to Allergan, best known for its Botox anti-wrinkle treatment. Wall Street had expected Tazoral’s annual sales to eventually reach $250 million, about the same as the Irvine-based company’s glaucoma products, which face generic competition.

Now the odds of Tazoral reaching the market have narrowed considerably. The FDA isn’t required to follow the advice of its panel of experts, but it typically does.

Allergan said in a statement that it was disappointed. The company said it would work closely with the FDA to address the issues raised by the panel. Allergan said it believed that Tazoral offered patients “a safe and effective option.”

Allergan’s shares closed off $3.27 at $81.91 in regular trading on the New York Stock Exchange after rising to $88.29 before the panel voted. In early after-hours trading, Allergan’s shares sank to $75.25. The company has scheduled a conference call with investors today.

Tazoral is a retinoid, a class of medications that includes Swiss drug maker Roche Holding’s Accutane and has been linked to birth defects. In a report released Friday, the FDA said Tazoral harmed animal fetuses at lower dosages than Accutane. Four women in Tazoral clinical trials became pregnant. Two had abortions, one had a miscarriage and the fourth gave birth to an apparently healthy child.

Allergan said Tazoral was intended for only the 1.5 million Americans with moderate to severe psoriasis, a skin condition that causes excessive flaking and itching. The company said that people with psoriasis were largely adults and that many were older than 40.

However, the company has tested Tazoral in patients with acne, a condition that affects 85% of people between the ages of 12 and 25. The company presented positive studies on Tazoral as an acne treatment at a medical meeting this year, and many panelists worried that the research could spur off-label use among young women and teens.

Also, Allergan markets an ointment with the same active ingredient as Tazoral for acne.

Sarah L. Sellers, a panelist and pharmacist from North Carolina, said the acne studies effectively established an off- label market for Tazoral.

“The company said it won’t promote it for this market,” she said. “But the market is already there.”

Allergan proposed mandatory pregnancy tests for all women of childbearing age before prescriptions are filled. The firm proposed that prescriptions would be limited to a 30-day supply and that no refills would be allowed. But some panelists worried that those measures would prove inadequate in the case of Tazoral, which is meant to be taken by patients indefinitely.

Accutane, by contrast, is taken for 20 days for acne and then stopped.

Some panelists said the majority on the panel was judging Tazoral by too high a standard and that other retinoids might not have been approved had they received the same scrutiny.

“I feel that we should approve this drug,” said panelist Jimmy Schmidt, a dermatologist from Houston. “I think there is a niche for this medication, and there are patients who will really benefit from this.”