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Ocrevus Patient Gets Progressive Multifocal Leukoencephalopathy (PML)

A May 24, 2017 Reuters news report, “Deadly brain infection in German MS patient prompts Roche investigation”, brings some unwanted attention to a potential drug safety issue for Ocrevus (ocrelizumab injection) which may negatively affect this projected sales success. From this recent Reuters article:

A person in Germany treated with Roche Holding AG’s new multiple sclerosis drug Ocrevus has been diagnosed with an often-deadly brain infection after switching from another medication earlier this year, the Swiss drugmaker said on Wednesday.

Roche said it was investigating a case of Progressive Multifocal Leukoencephalopathy (PML) in a patient previously being treated for three years with Biogen Inc’s Tysabri and who had received a single dose of Ocrevus in February.

Roche is trying to determine the source of the illness but MS drugs that suppress the immune system can increase the risk of serious infections.

Ocrevus was approved in the United States in March.

Roche said the case of the rare brain disease that is usually fatal or disabling was reported as a carry-over from Tysabri, also known as natalizumab, by the physician who had been treating the patient.

Biogen issued a statement that made no mention of the possible Tysabri connection to the case….

Roche has said no PML cases emerged during its trials of Ocrevus, but the company included warnings to patients taking the medication that there was a risk they could get the disease.

In the Prescribing Information for Ocrevus (accessed 5/25/17), in the Warnings and Precautions section, at part 5.2 Infections, one finds a warning about Progressive Multifocal Leukoencephalopathy (PML).

We will continue to follow this possible safety issue for Ocrevus, a new multiple sclerosis (MS) drug from Genentech and Roche.

[Read this article in full at original source]

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