Tysabri Approved for Crohn's Disease
TUESDAY, Jan. 15 (HealthDay News) --
Tysabri (natalizumab) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe Crohn's disease in people who haven't responded to other therapies.
Tysabri, made by the Ireland-based drugmaker Elan and Massachusetts-based Biogen Idec, was approved in 2006 to treat relapsing multiple sclerosis.
The drug has a boxed warning of increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection affecting the brain that could cause severe disability or death, the FDA said in a statement. Anaphylactic reactions and liver injury also have been reported in some users.
Crohn's patients prescribed the drug will be enrolled in a restricted distribution program called Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD-TOUCH). Under the program, physicians must evaluate Crohn's patients using Tysabri after three months and should discontinue use of the drug if there is no improvement, the FDA said.
Crohn's is an incurable bowel disease with symptoms that may include diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestines, cramping, and abdominal pain. The disease, affecting more than 1 million people worldwide, can also lead to abnormal connections called fistulas from the intestines to the skin or internal organs.
More about Tysarbi:
Elan Corp., Ireland's biggest drugmaker, and partner Biogen Idec Inc. won U.S. approval for the use of their multiple sclerosis medicine Tysabri as a treatment for Crohn's disease.
The Food and Drug Administration issued its determination in an e-mailed statement today. Elan and Biogen said in a separate statement that they expect Tysabri to be available to Crohn's patients by the end of February, once an FDA-approved plan to minimize risks of the drug is in place.
The companies are trying to expand the use of the medicine, which brought in $93 million in the third quarter. Tysabri is taken by about 21,000 MS patients under prescribing restrictions because of a risk of rare, fatal brain infections. Similar rules will be used in treating Crohn's disease, a chronic inflammation of the intestines that affects about 1 million people worldwide.
The approval is ``an important step in the armamentarium for treatment but one that carries extreme risks,'' said Joyce Korvick, deputy director of the FDA's office of new gastroenterology drugs, on a conference call with reporters.
Other therapies for Crohn's include Abbott Laboratories' anti-inflammatory medicine Humira, which exceeded $3 billion in global sales for the first time in 2007, Abbott Chief Financial Officer Thomas Freyman said on Jan. 7.
Dublin-based Elan discovered Tysabri, and is developing the medicine as a Crohn's treatment. Its partner Biogen, based in Cambridge, Massachusetts, lost more than $5 billion in market value in December after announcing it failed to find a buyer and planned to remain independent.
Biogen rose 90 cents, or 1.5 percent, to $59.92 at 4 p.m. New York time in Nasdaq Stock Market composite trading. Elan's American depositary receipts, each equal to one ordinary share, rose 10 cents, or less than one percent, to $24.86.
Pulled From Market
Tysabri was the best hope in a decade for MS patients when it was approved in November 2004. It was pulled from the market three months later because of links to a neurological disorder called progressive multifocal leukoencephalopathy, or PML. Three patients contracted the disease, and two died.
About 14,000 patients have been treated with Tysabri since it was returned to the market as a multiple sclerosis drug in July 2006. No cases of PML have been reported. An advisory panel to the FDA voted 12-3 last July to recommend approval of the added use for Tysabri for Crohn's disease, with restrictions to reduce the risk of infection.
In October, the FDA extended its review. A month later, European regulators rejected an appeal by Elan and Biogen of an earlier decision that the product not be approved and marketed for Crohn's.