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FDA Raps Biogen's Plan to Track MS Drug's Safety

Posted on: Wednesday, 8 March 2006, 12:00 CST

By Jeffrey Krasner, The Boston Globe

Mar. 8--A day before the start of a crucial Food and Drug Administration review of the multiple sclerosis drug Tysabri, the agency released a report criticizing plans by drug makers Biogen Idec Inc. and Elan Corp. PLC to monitor the use of the drug and track the health of patients.

But analysts and doctors said the 13-page report appears unlikely to derail efforts to return the drug to the market, and another FDA report released yesterday showed Biogen Idec, of Cambridge, had already responded to some concerns raised by the agency's Office of Drug Safety.

"Clearly the drug is going to come back," said William Tanner, an analyst with Leerink Swan & Co "The drug safety people are not asking them to reinvent the wheel. They're asking them to be more rigorous in their risk-minimization plan."

If the Office of Drug Safety had more serious concerns, Tanner said, it could have required an additional clinical trial, potentially delaying the reintroduction of the drug by years.

Tim Hunt, a Biogen Idec spokesman, said the company has been working with the FDA since February 2005, when Biogen Idec and Elan voluntarily withdrew Tysbari from the market after two patients taking it in a trial contracted a rare brain disease. Ultimately, three patients in trials were found to have the disease, and two died.

"Our risk-management plan will continue to evolve with the FDA, as it has in recent weeks," Hunt said.

Yesterday's news did not seem to rattle investors. Biogen Idec shares gained one cent to close at $45.51 on a day when broad market indexes declined sharply. Elan shares gained 20 cents to close at $12.70.

Tysabri was considered an extremely promising treatment when it went on sale in November 2004. In some clinical trials, it seemed to show twice the benefit of other first-line treatments for multiple sclerosis, according to an FDA briefing for the meeting.

Two weeks ago, the FDA gave Biogen Idec permission to restart clinical trials of Tysabri. But the drug's commercial fate rests largely on hearings scheduled for today and tomorrow. Patients, doctors, and others will have a chance to speak about whether Tysabri should be sold again. The meeting was extended to two days after numerous patients sought to speak at the hearing.

The advisory committee will vote after the sessions conclude and its recommendation will go to the FDA. Although it is not binding, such recommendations usually predict how the agency will act.

"I want Tysabri back," said Dr. Mark Gudesblatt, medical director of South Shore Neurological Associates, a large private practice in Bayshore, N.Y. "There are people I take care of that are on every medication or combination you can think of, and they're doing poorly. I want another option."

One issue the FDA wants addressed is how Biogen Idec and Elan will oversee patients and doctors if Tysabri is brought back. The Office of Drug Safety wrote that the original plan submitted by Biogen Idec "does not adequately address the risk" of the rare brain disease, progressive multifocal leukoencephalopathy.

In that plan, Biogen Idec had proposed that doctors and patients sign up voluntarily for a registry to track their experience with the drug. The drug safety office said all patients should be followed, regardless of how long they use Tysabri. In a subsequent memo, Biogen Idec proposed as part of a risk program that the registry be made mandatory.

Other specific recommendations of the safety committee that were detailed in the 13-page memo included:

Steps to prevent doctors from prescribing Tysabri to treat diseases other than multiple sclerosis. For instance, Tysabri is still being studied as a possible treatment for Crohn's disease, an intestinal ailment.

Closer control of Tysabri supplies, to ensure that only people participating in the risk program receive the drug.

Restricting Tysabri to certain multiple sclerosis patients, such as those who aren't responding to existing drugs.

"It's reasonable to insist that physicians register with the safety plan, that patients register, and that infusion centers register, so that patient is being followed and if anything happens to that patient, it is brought to the attention of the scientific community," said Dr. R. Philip Kinkel, director of the Multiple Sclerosis Center at Beth Israel Deaconess Medical Center.

"We need to closely monitor patients that go on treatment, and we need further information as to how to minimize the risk of PML or any other adverse outcome."

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BIIB, ELN,

Source: The Boston Globe

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