- Roche’s biotech division Genentech confirmed Wednesday evening that there has been a case of a deadly brain disease in a patient taking its newly launched multiple sclerosis (MS) drug.
- The company confirmed that a patient taking Ocrevus (ocrelizumab) developed progressive multifocal leukoencephalopathy (PML) after taking Biogen’s Tysabri (natalizumab) for three years prior. The patient stopped receiving Tysabri in February and had one dose of Ocrevus in April.
- The case of PML occurred in a JCV-positive patient — this virus is generally considered an indicator of susceptibility to the brain illness.
"The case was reported as a carry-over from natalizumab by the treating physician. Patient safety is Roche’s highest priority and we are gathering more details about the case and the patient’s history. We will continue to share information with healthcare providers and global health authorities as we know more," Roche said in a statement.
The closely watched Ocrevus was just approved by the Food and Drug Administration at the end of March and has been on the market for less than two months.
The drug, green lit for both the relapsing-remitting form of the disease as well as the primary progressive form, is expected to be a market disrupter. The drug was the first medication approved for primary progressive MS – a hurdle that many of the other drugs on the market have failed to clear, despite extensive clinical studies.
Yet, PML has long plagued MS patients and drug developers. Biogen’s Tysabri was once considered the most effective drug on the MS market, but it is also the most widely associated with PML. Despite the drug's high rate of efficacy, sales have always been stifled by the potential for PML. Tysabri was even taken off the market briefly in 2005 due to the deadly side effect (the FDA allowed it to return once Biogen found a way to test for susceptibility of the disease).
Tysabri isn’t the only MS drug to cause this side effect either; both Novartis’ Gilenya (fingolimod) and Biogen’s blockbuster Tecfidera (dimethyl fumarate) have reported cases.
While this newest case is unlikely to hurt the prospects for Ocrevus at this point, it's a reminder that physicians need to stay vigilant even in the face of promising new drugs.