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New MS drug in spotlight after patient is diagnosed with deadly brain infection | New MS drug in spotlight after patient is diagnosed with deadly brain infection |
(about 13 hours later) | |
A new multiple sclerosis drug is under investigation after a patient who received it was diagnosed with a deadly brain disease. | A new multiple sclerosis drug is under investigation after a patient who received it was diagnosed with a deadly brain disease. |
The patient was reportedly treated with the drug Tysabri from Biogen for three years before receiving a single dose of the new drug Ocrevus by Roche in April. The subject later developed a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML) which often results in “serious disability or death”. | The patient was reportedly treated with the drug Tysabri from Biogen for three years before receiving a single dose of the new drug Ocrevus by Roche in April. The subject later developed a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML) which often results in “serious disability or death”. |
Roche said it is investigating the cause of the infection with the patient’s previous diagnosis for John Cunningham virus being considered as a possible source. | Roche said it is investigating the cause of the infection with the patient’s previous diagnosis for John Cunningham virus being considered as a possible source. |
The Swiss drugmaker acknowledged that, while there were no cases of PML recorded during its trials of Ocrevus, patients taking the drug were warned that there was a possible risk of developing a serious infection. | The Swiss drugmaker acknowledged that, while there were no cases of PML recorded during its trials of Ocrevus, patients taking the drug were warned that there was a possible risk of developing a serious infection. |
The risk is associated with all MS drugs that suppress the immune system. Dozens of patients undergoing treatment with Tysabri have been diagnosed with PML in the past, Reuters reports. | The risk is associated with all MS drugs that suppress the immune system. Dozens of patients undergoing treatment with Tysabri have been diagnosed with PML in the past, Reuters reports. |
The US Food and Drug Administration (FDA) approved Ocrevus for use in the country in March. | |
The regulator took Tysabri off the market in 2005 after three patients involved in a clinical trial developed PML. But the drug was later reinstated with additional guidelines after users, for whom it was effective, demanded its return. | |
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Roche claims the diagnosis was reported as a carry-over from Tysabri, otherwise known as natalizumab, by the patient’s physician. However, Tysabri manufacturer Biogen’s statement on the matter makes no mention of a possible connection to its drug. | |
"Biogen is aware that a patient taking Ocrevus has been diagnosed with PML, and we are currently assessing the information to confirm the reported PML," Biogen spokesman Matt Fearer told Reuters. | "Biogen is aware that a patient taking Ocrevus has been diagnosed with PML, and we are currently assessing the information to confirm the reported PML," Biogen spokesman Matt Fearer told Reuters. |
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