Patient diagnosed with rare brain infection linked to Roche's new MS drug

A German patient was diagnosed with a potentially life-threatening brain infection after switching from Biogen's multiple sclerosis drug Tysabri to Roche's new Ocrevus MS treatment, reports Reuters.

Here are four things to know.

1. The patient switched to Ocrevus in February after taking Tysabri for three years. Clinicians diagnosed the patient with progressive multifocal leukoencephalopathy — a rare, often fatal illness causing progressive damage or inflammation to the brain. MS drugs suppress the immune system and can increase the risk of serious infection, reports Reuters.

2. Roche on Wednesday said it was investigating the case to determine the source of the illness. The drugmaker said a physician who treated the patient reported the brain infection as a "carry-over" from taking Tysabri, according to the report.

3. Dozens of patients treated with Tysabri have developed the rare brain disease, according to Reuters. Regulators prohibited use of the drug 10 years ago, but brought it back to the market with stronger use restrictions following large patient demand.

"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," Matt Fearer, a Biogen spokesman, told Reuters.

4. No patients developed the rare brain infection during Roche's clinical trial for Ocrevus, the drugmaker said. Roche did include warnings on Ocrevus' label regarding the potential to develop the infection, according to the report.

"Patient safety is Roche's highest priority, and we are gathering more details about the case and the patient's history," a Roche spokesperson told Reuters. "We will continue to share information with healthcare providers and global health authorities as we know more."

More articles on supply chain:

Biogen offshoot to acquire rare disease biotech for $400M: 4 things to know
Why FDA's newest approval paves the way for precision medicine
Supply chain tip of the day: How pharmacy can drive revenue for a health system post-merger

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars