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New MS Drug Ocrevus Gets Possible Bad News About Side Effects Soon After Good News About Sales Projections

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.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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40 responses to “New MS Drug Ocrevus Gets Possible Bad News About Side Effects Soon After Good News About Sales Projections”

  1. JA Avatar
    JA

    While the world awaits further news on Ocrevus and PML, the real news is PML induced by Tysabri and how many of the 700-800 patients who have been stricken with PML, if any, did NOT have JCV Ab testing done as recommended by the FDA because treating physicians did not check for JCV Ab status q 6 monthly as they ought to and yet the drug was given like clockwork. Hence, what good is the REMS program ?
    JA

    Reply
  2. JA Avatar
    JA

    While the world awaits further news on Ocrevus and PML, the real news is PML induced by Tysabri and how many of the 700-800 patients who have been stricken with PML, if any, did NOT have JCV Ab testing done as recommended by the FDA because treating physicians did not check for JCV Ab status q 6 monthly as they ought to and yet the drug was given like clockwork. Hence, what good is the REMS program ?
    JA

    Reply
  3. JA Avatar
    JA

    PML is a much more of a problem with Tysabri and the latest PML count is > 730, worldwide, if my numbers are correct, in Tysabri users. The single query that remains unanswered is this – how many of these patients, IF ANY, did not have JCV Ab testing done every 6 mo as recommended ? As well, why doesn’t FDA investigate every single case and have this data out in the public ? As an MS physician, I need to know these numbers as well and for patients this is critical since they can remind their doctors to get the test done every 6 mo if such cases exist although the doc should be the one ordering this test anyway, as per the guidelines !!!
    As for this recent Ocrevus case of PML, it will be intriguing to know what the findings will be.

    Reply
  4. JA Avatar
    JA

    PML is a much more of a problem with Tysabri and the latest PML count is > 730, worldwide, if my numbers are correct, in Tysabri users. The single query that remains unanswered is this – how many of these patients, IF ANY, did not have JCV Ab testing done every 6 mo as recommended ? As well, why doesn’t FDA investigate every single case and have this data out in the public ? As an MS physician, I need to know these numbers as well and for patients this is critical since they can remind their doctors to get the test done every 6 mo if such cases exist although the doc should be the one ordering this test anyway, as per the guidelines !!!
    As for this recent Ocrevus case of PML, it will be intriguing to know what the findings will be.

    Reply
  5. CATHERINE ANDRESEN Avatar
    CATHERINE ANDRESEN

    My daughter is not better on Ocrevous

    Reply
  6. CATHERINE ANDRESEN Avatar
    CATHERINE ANDRESEN

    My daughter is not better on Ocrevous

    Reply
  7. CcG Avatar
    CcG

    My dr has me all signed up and I’m to start treatment with Ocrevus later this month. I have been tested and am positive for JCV virus. I don’t think I want to do it he says the risk is low, but I guess I’m scared.

    Reply
  8. CcG Avatar
    CcG

    My dr has me all signed up and I’m to start treatment with Ocrevus later this month. I have been tested and am positive for JCV virus. I don’t think I want to do it he says the risk is low, but I guess I’m scared.

    Reply
  9. Peggy Avatar
    Peggy

    I too am all signed up and am positive for the JC virus. Supposed to start August 29. I think I am going to cancel. MS is bad enough without possibly adding pml.

    Reply
  10. Peggy Avatar
    Peggy

    I too am all signed up and am positive for the JC virus. Supposed to start August 29. I think I am going to cancel. MS is bad enough without possibly adding pml.

    Reply
  11. Tom Lamb Avatar
    Tom Lamb

    Patient Advisory: The prescription drugs discussed on this site are approved for use by the the Food and Drug Administration (FDA). Patients should not stop taking any prescription drug without seeking the advice of their medical doctor.
    Tom Lamb

    Reply
  12. Tom Lamb Avatar
    Tom Lamb

    Patient Advisory: The prescription drugs discussed on this site are approved for use by the the Food and Drug Administration (FDA). Patients should not stop taking any prescription drug without seeking the advice of their medical doctor.
    Tom Lamb

    Reply
  13. robert Avatar
    robert

    The patient should be taking some responsibility on insisting on JC viral testing. In order to reup the treatment every 6 months the prescribing neurologist has to answer the question when the patient has the last JC viral titer test and what was the result.

    Reply
  14. robert Avatar
    robert

    The patient should be taking some responsibility on insisting on JC viral testing. In order to reup the treatment every 6 months the prescribing neurologist has to answer the question when the patient has the last JC viral titer test and what was the result.

    Reply
  15. Dr. Mac Avatar
    Dr. Mac

    The prescribing MD, and I am assuming it is a neurologist, is required to answer whether the patient had recent JC testing and what was the result prior to reupping another 6 months of treatment. The patient bears some responsibility to make certain that it is done. I have had patient’s that ignore the request for JC testing yet become upset when I tell them that they are not getting anymore Tsyabri until it is done. I supect the reason for their recalcitrance it they have to come in every 6 months to see me before Tysabri is re-authorized.

    Reply
  16. Dr. Mac Avatar
    Dr. Mac

    The prescribing MD, and I am assuming it is a neurologist, is required to answer whether the patient had recent JC testing and what was the result prior to reupping another 6 months of treatment. The patient bears some responsibility to make certain that it is done. I have had patient’s that ignore the request for JC testing yet become upset when I tell them that they are not getting anymore Tsyabri until it is done. I supect the reason for their recalcitrance it they have to come in every 6 months to see me before Tysabri is re-authorized.

    Reply
  17. narelle7000@gmail.com Avatar
    narelle7000@gmail.com

    what would be the side effects of of coming of Ocrevus after the ist half infusion?

    Reply
  18. narelle7000@gmail.com Avatar
    narelle7000@gmail.com

    what would be the side effects of of coming of Ocrevus after the ist half infusion?

    Reply
  19. Tom Lamb Avatar
    Tom Lamb

    Thank you for your inquiry.
    Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation.
    I wish you the best in all aspects going forward.
    Have a good day.
    Tom Lamb

    Reply
  20. Tom Lamb Avatar
    Tom Lamb

    Thank you for your inquiry.
    Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation.
    I wish you the best in all aspects going forward.
    Have a good day.
    Tom Lamb

    Reply
  21. Libby Avatar
    Libby

    I did NOT have the JC virus prior to my 1st infusion and now I do. Is there any answer or anyone who will answer questions

    Reply
  22. Libby Avatar
    Libby

    I did NOT have the JC virus prior to my 1st infusion and now I do. Is there any answer or anyone who will answer questions

    Reply
  23. Steve Hecht Avatar
    Steve Hecht

    Hello Catherine;
    It’s almost mid-May 2018 now. How is your daughter these many months later? Is she still no better at all; & if so, has she received a 2nd Ocrevus infusion, w/still no positive results?
    2) Or is the MS even worse now than when last you wrote? If so, do you have any awareness (even “just” an inchoate or intuitive one @ this point) that there may be some possible link between the continued worsening of the MS & the presence of the Ocrevus in her body?
    3) Or did she finally seem to begin to receive some modicum of benefit from the Ocrevus? If it’s the 3rd case, would you also be willing to share what types(s) of benefit — how significant the 1 or more benefit(s) have been, &/or are they only partial, & perhaps not even stable (i.e., reliable) benefits she can count on 24/7? Lastly, if any benefit(s) did finally seem to appear, how slowly or rapidly was the onset?
    I really hope you don’t mind my questions, but I want you to know I sat straight up & paid immediate attention when reading your August 2017 post. The history of medicine — indeed, of science, period — is replete w/ proven examples of the fact that so-called “outlie-r” cases like your daughter’s often end up becoming recognized as very important signposts, & thus should not be ignored by the public nor by Big Pharma.
    Oh, yes — PS :: Has your daughter been tested for the JCV at any point in this journey so far; & if so, what was the result? At least 1 person here seems to be saying s/he didn’t test positive for the virus before receiving the 1st Ocrevus infusion, yet then after the infusion did then end up testing positive for JCV. If that’s correct, that suggests a whole separate possible can of worms must also be rigorously examined & considered.

    Reply
  24. Steve Hecht Avatar
    Steve Hecht

    Hello Catherine;
    It’s almost mid-May 2018 now. How is your daughter these many months later? Is she still no better at all; & if so, has she received a 2nd Ocrevus infusion, w/still no positive results?
    2) Or is the MS even worse now than when last you wrote? If so, do you have any awareness (even “just” an inchoate or intuitive one @ this point) that there may be some possible link between the continued worsening of the MS & the presence of the Ocrevus in her body?
    3) Or did she finally seem to begin to receive some modicum of benefit from the Ocrevus? If it’s the 3rd case, would you also be willing to share what types(s) of benefit — how significant the 1 or more benefit(s) have been, &/or are they only partial, & perhaps not even stable (i.e., reliable) benefits she can count on 24/7? Lastly, if any benefit(s) did finally seem to appear, how slowly or rapidly was the onset?
    I really hope you don’t mind my questions, but I want you to know I sat straight up & paid immediate attention when reading your August 2017 post. The history of medicine — indeed, of science, period — is replete w/ proven examples of the fact that so-called “outlie-r” cases like your daughter’s often end up becoming recognized as very important signposts, & thus should not be ignored by the public nor by Big Pharma.
    Oh, yes — PS :: Has your daughter been tested for the JCV at any point in this journey so far; & if so, what was the result? At least 1 person here seems to be saying s/he didn’t test positive for the virus before receiving the 1st Ocrevus infusion, yet then after the infusion did then end up testing positive for JCV. If that’s correct, that suggests a whole separate possible can of worms must also be rigorously examined & considered.

    Reply
  25. Steve Hecht Avatar
    Steve Hecht

    Hi Libby,
    I just tried posting a reply to Catherine Andresen’s 08/04/17 comment, and I mentioned your experience at the very end b/c it’s clearly very important. Please read that & & comment, if you’re so inclined. I am also quite struck by your choice of words in the question “Is there any answer, or anyone who will answer questions?”. I hear you. Quite amazing that nothing’s been posted in reply to your words whatsoever — — not even a flicker of interest displayed. Mind boggling….

    Reply
  26. Steve Hecht Avatar
    Steve Hecht

    Hi Libby,
    I just tried posting a reply to Catherine Andresen’s 08/04/17 comment, and I mentioned your experience at the very end b/c it’s clearly very important. Please read that & & comment, if you’re so inclined. I am also quite struck by your choice of words in the question “Is there any answer, or anyone who will answer questions?”. I hear you. Quite amazing that nothing’s been posted in reply to your words whatsoever — — not even a flicker of interest displayed. Mind boggling….

    Reply
  27. Kathleen Avatar
    Kathleen

    About to take my 2yr dose of Ocrevus. Never had sinus problems b4. have had 2 sinus infections since. Seasonal allergy now causing sinus pain. Don’t know if its an infection but now fearful of 6mos dose scheduled next week that it may lead to sinus infection which wiped me out last year.

    Reply
  28. Kathleen Avatar
    Kathleen

    About to take my 2yr dose of Ocrevus. Never had sinus problems b4. have had 2 sinus infections since. Seasonal allergy now causing sinus pain. Don’t know if its an infection but now fearful of 6mos dose scheduled next week that it may lead to sinus infection which wiped me out last year.

    Reply
  29. Sherri Avatar
    Sherri

    I was on Ocrevus for one year. During that time, my symptoms resulted in a complete hysterectomy and now cardiomyopathy (heart failure). I’m only 47-year-old. Now I wish I never took any of these disease-modifying drugs and let the MS take its course naturally.

    Reply
  30. Sherri Avatar
    Sherri

    I was on Ocrevus for one year. During that time, my symptoms resulted in a complete hysterectomy and now cardiomyopathy (heart failure). I’m only 47-year-old. Now I wish I never took any of these disease-modifying drugs and let the MS take its course naturally.

    Reply
  31. WENDY N. Avatar
    WENDY N.

    I started Ocrevus is May 2019, it is now Oct 2019. I have been in the worst shape ever, the past two months, since my diagnosis in 2001. I just learned that my JC virus testing that was done in January 2019 was tested positive. I wasn’t aware that is what links to PML and I am increasingly concerned about whether I should get my next infusion due next month. Has anybody else on here already started and had a positive JC virus testing. If so what does that mean? Is it safe to continue. My family is worried and so am I due to the fact that I have deteriorated so badly the past few months. I have already had to go through two rounds of 3 day IV steroid infusions (1,000mg ) at the hospital for three days in the past month. Adcvice please.

    Reply
  32. WENDY N. Avatar
    WENDY N.

    I started Ocrevus is May 2019, it is now Oct 2019. I have been in the worst shape ever, the past two months, since my diagnosis in 2001. I just learned that my JC virus testing that was done in January 2019 was tested positive. I wasn’t aware that is what links to PML and I am increasingly concerned about whether I should get my next infusion due next month. Has anybody else on here already started and had a positive JC virus testing. If so what does that mean? Is it safe to continue. My family is worried and so am I due to the fact that I have deteriorated so badly the past few months. I have already had to go through two rounds of 3 day IV steroid infusions (1,000mg ) at the hospital for three days in the past month. Adcvice please.

    Reply
  33. KATHLEEN SUMMERS Avatar
    KATHLEEN SUMMERS

    2 sinus infections, yeast infection and urinary infections. Just got back from 5 day stint in hospital for C diff infection. Ive had 4 infusions. As convenient as the 6 mos therapy is i dont believe its worth it. I also never had sinus problems prior to Ocrevus.

    Reply
  34. KATHLEEN SUMMERS Avatar
    KATHLEEN SUMMERS

    2 sinus infections, yeast infection and urinary infections. Just got back from 5 day stint in hospital for C diff infection. Ive had 4 infusions. As convenient as the 6 mos therapy is i dont believe its worth it. I also never had sinus problems prior to Ocrevus.

    Reply
  35. Alex Avatar
    Alex

    Hi Sherri, This is the first I’ve heard of Ocrevus resulting in the need for a hysterectomy or cardiomyopathy. Please can you share what resulted in the need for a hysterectomy?

    Reply
  36. Alex Avatar
    Alex

    Hi Sherri, This is the first I’ve heard of Ocrevus resulting in the need for a hysterectomy or cardiomyopathy. Please can you share what resulted in the need for a hysterectomy?

    Reply
  37. Alex Avatar
    Alex

    Any recent updates on people’s experiences of Ocrevus?

    Reply
  38. Alex Avatar
    Alex

    Any recent updates on people’s experiences of Ocrevus?

    Reply
  39. Richelle Lewis Avatar
    Richelle Lewis

    OCREVUS My Husband had this treatment and i do believe it had something to do with his death, after this treatment he had headaches, eyesight problem, and then offset borderline diabetes, never before that treatment did he have borderline diabetes so I do believe it side effects it comes from that treatment, 2 weeks after that treatment my husband died check ✔ all your information on this drug,,,before having it ,like C19 they dont check these drug with different health problem before give it out..

    Reply
  40. Richelle Lewis Avatar
    Richelle Lewis

    OCREVUS My Husband had this treatment and i do believe it had something to do with his death, after this treatment he had headaches, eyesight problem, and then offset borderline diabetes, never before that treatment did he have borderline diabetes so I do believe it side effects it comes from that treatment, 2 weeks after that treatment my husband died check ✔ all your information on this drug,,,before having it ,like C19 they dont check these drug with different health problem before give it out..

    Reply

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