Biogen confident on Tysabri
Mullen expects FDA to rule by June 30 on restarting sales
Biogen Idec Inc.'s chief executive, James C. Mullen, said he expects the Food and Drug Administration to rule by June 30, 2006, on the company's application to restart sales of its multiple sclerosis drug Tysabri.
Mullen said he expects the European Medicines Agency, which is considering initial approval of Tysabri for sale in European Union countries, to act by the same time.
In an interview with Boston Globe editors and reporters, Mullen spoke with confidence about Tysabri's return, at one point speculating about ''when it comes back."
''Tysabri still looks like a product that can really stop the disease progression in multiple sclerosis," Mullen said.
Problems with Tysabri have consumed much of Mullen's time this year. The product, considered a breakthrough from existing MS treatments because of its effectiveness in preventing debilitating relapses, was approved for sale in November. But Biogen Idec and its partner in the drug, Elan Corp. of Ireland, voluntarily suspended sales in February when one patient died of a rare brain disease, and another was suspected of having contracted the disease.
Ultimately, three patients taking Tysabri in clinical trials were diagnosed with the disease, called progressive multifocal leukoencephalopathy. Two died and one recovered. The virus that causes PML exists in suspended animation in many people, but it usually doesn't become active and cause disease unless a person's immune system isn't working properly. Prior to the Tysabri-related cases, PML had often been seen as an opportunistic infection striking AIDS patients whose immune systems are severely damaged.
Biogen Idec and Elan on Monday said they had completed an exhaustive safety review of Tysabri working with disease specialists and physicians from the National Institutes of Health.
After reexamining all the patients who participated in clinical trials of Tysabri, and those who took the drug during its brief time on the market, the companies said they didn't find any other cases of PML.
The companies submitted an application to the FDA for a revised license to start selling Tysabri on Sept. 26. The agency has 60 days to decide whether it will give the application priority review, which calls for a finding within six months, or give the application standard 10-month review.
Mullen said he expected the review process would include an FDA-appointed advisory panel. Such panels, made up of medical experts meet publicly and vote on a recommended course of action for the FDA. Though not binding, such committee recommendations usually form the basis for the agency's ultimate decision.
The review of Tysabri showed that doctors should avoid prescribing the drug to patients with weakened immune systems. In particular, he said, the drug should be kept away from patients who have taken drugs with a known immunosuppressive effect.
Mullen declined to say whether those conditions are included in a suggested revised warning label Biogen Idec submitted to the FDA.
''We want to educate physicians and neurologists to be on the alert for PML," he said. ''We don't think we've got the magic way to eliminate the risk, but we want the doctors to make sure they put PML on the top of the list" of potential side effects.
Mullen said he didn't think Tysabri should be restricted to a small subset of MS patients, because none of the existing treatments halts the long-term progression of the disease.
Before the safety review was completed, some doctors said they thought the drug should only be prescribed to those that haven't responded to other treatments.
Art Mellor, chief executive of the Accelerated Cure Project, a nonprofit group in Waltham devoted to determining the causes of MS, said he expected demand for Tysabri would be strong if there are no new complications.
''I'm going to guess there'll be some initial cautiousness following the reintroduction," he said.
''But once people see others aren't getting sick, then the floodgates will open. There are plenty of people who are not responding to any of the other treatments and are getting worse. They're not going to hesitate."
Jeffrey Krasner can be reached at krasner@globe.com.