Ocrevus - Progressive Multifocal Leukoencephalopathy (PML) Reported As Possible Side Effect In Germany, Says Drug Maker Roche
(Posted by Tom Lamb at DrugInjuryWatch.com)
In March 2017 the FDA approved Ocrevus (ocrelizumab injection) for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis (MS).
According to this May 22, 2017 article, "Top 8 New Drugs to Watch for 2021", Ocrevus is projected to be a so-called "blockbuster drug" within the next several years:
The 2017 “Drugs to Watch” report from Clarivate Analytics Cortellis Competitive Intelligence, predicts that Ocrevus (ocrelizumab, from Genentech and Roche), will be a top seller in coming years.
“Twice yearly injection reduces the rate of relapse of the disease by 46% more than that of the former standard of care, Rebif,” wrote Alexandra Kibble, senior editor for Clarivate, in a blog post. As a result, Ocrevus will produce a projected $3.33 billion in sales in 2021.
In addition, Ocrevus is the first drug to prove effective in primary progressive MS, an aggressive form. “The drug also delays disease progression and reduces the number of new brain lesions,” Kibble wrote
However, this 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 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.
"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 said in a statement.
He added that there are many unknowns around the safety of long-lasting drugs of this type "including occurrence and management of opportunistic infections."...
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.
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In the Prescribing Information for Ocrevus (accessed 5/25/17), in the Warnings and Precautions section, at part 5.2 Infections, one finds such a warning:
Progressive Multifocal Leukoencephalopathy (PML)
PML is an opportunistic viral infection of the brain caused by the John Cunningham (JC) virus that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. Although no cases of PML were identified in OCREVUS clinical trials, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants)....
We will continue to follow this possible safety issue for Ocrevus, a new multiple sclerosis (MS) drug from Genentech and Roche.
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