Roche initiates Ocrevus review after multiple reported patient deaths in multiple sclerosis leave usage, causality concerns and open questions – sources
Multiple reported patient deaths through the FDA reporting system for patients taking Roche’s (VTX:ROG) Ocrevus (ocrelizumab) for multiple sclerosis has led to the company launching an investigation into the cases, said a source familiar with the situation. Two additional sources familiar with the drug said they also heard about the deaths, adding a number of questions regarding the nature of the cases remain unanswered.
The deaths have yet to be reported in a press release or Roche’s SEC filings. The FDA adverse reporting system (FDAERS) lists a total of 21 deaths for ocrelizumab across all indications since its clinical development began, though in a number of cases does not detail the cause of death or the patient indication. The FDAERS also does not note whether the deaths are drug related. Despite a lack of information on most cases, a few with details include myocardial infarction, cardiac disorder and sepsis.
One source noted he had heard from the company of at least 15 reported deaths, whilst a second noted he had heard from multiple clinicians of five reported deaths. A third source confirmed he had heard anecdotal reports of patient deaths but did not have an exact number.
Whilst there may be 15 reports, the nature of the FDA reporting system means that often one case may be reported multiple times so the actual number is likely to be lower than 15, the first source noted.