Lauren Hoffman is Waiting on Tysabri: MS patients line up as the drug returns to market
"It's the best thing that has come along for a long time," Hoffman said. "It keeps me from getting worse."
On Monday, Hoffman received an e-mail message saying that Tysabri is on its way to the only approved distributor and 12 specialty pharmacies allowed to sell it. That means Hoffman could get a Tysabri infusion at her physician's office within five to 10 weeks.
The possible risks and side effects spelled out in the Biogen e-mail gave her some pause, Hoffman said. "But I still want to get back on it," she said.
Tysabri works by stopping infection-fighting T-cells from entering the brain, where they can cause the inflammation and scarring that progressively reduce MS patients' mobility and muscle control.
No other available MS treatment works as well, analysts and physicians say.
But its potency comes at a price: T-cells are an important part of the immune system. By interfering with them, Tysabri makes MS patients vulnerable to herpes infections and PML, a viral infection that typically leads to death or severe disability. Biogen also acknowledged that patients receiving Tysabri have come down with other atypical infections.
The possible side effects pose a dilemma for physicians.
"Everybody is excited, but also a little concerned," said Dr. Mitch Freedman of Raleigh Neurology. The practice treats about 2,000 MS patients.
Hoffman is among about a dozen patients Freedman plans to put back on Tysabri. That's a fraction of the 100 patients who were lined up for a prescription 18 months ago, Freedman said.
Dr. Ugo Goetzel of Millennium Neurology in Durham has whittled the number of patients who will receive Tysabri to a handful.
Both physicians agreed it is wise to limit the drug to patients who cannot tolerate other MS treatments or whose symptoms have gotten worse despite treatment with other drugs.
Hoffman went back on Avonex, another Biogen MS drug, when Tysabri was pulled. But Avonex made her very tired and gave her flu-like aches and pains the day after each weekly injection, she said.
The conditions that Biogen, Elan and regulators agreed on to bring Tysabri back are extensive. They include close patient monitoring for signs of PML. Physician offices must receive training before they can prescribe and administer Tysabri infusions. Prescription refills must be authorized by Biogen every six months. Also, Tysabri should not be given to patients with weakened immune systems.
Despite the safeguards, Freedman and Goetzel said they remain uneasy about Tysabri. They said they will feel better once more data on Tysabri is available from the monitoring program.......[click blue link above for full article]"
