What’s the news?
The multiple sclerosis community has been eagerly awaiting the approval of the drug Ocrevus (ocrelizumab), which will be used to treat patients who have relapsing MS (RMS) and primary progressive MS (PPMS). The FDA’s decision of final approval came on March 28, coinciding with Multiple Sclerosis Awareness Week.
Ocrelizumab is the first and only investigational drug
- to show greater efficacy in both RMS and PPMS in clinical studies.
- to consistently and significantly reduce disease activity and disability progression compared with a standard-of-care high-dose interferon (Rebif®).
- to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study (ORATORIO).
- that has the potential to address an important unmet need in MS.
What is Multiple Sclerosis?
MS is a chronic, typically progressive disease involving damage to the sheaths of nerve cells in the brain and spinal cord.
Patients with MS may show paresthesias (tingling sensation), blurred vision, optic neuritis (painful unilateral vision loss), clumsiness, muscle weakness, cognitive decline, and urinary dysfunction. Unfortunately, the neuron in the picture is also feeling some of these signs. The Lhermitte sign is caused when neck flexion creates electric shock-like sensations down the back and limbs.
Types of MS
1. Clinically Isolated Syndrome (CIS) First episode of neurologic symptoms caused by inflammation and demyelination in the central nervous system.
2. Relapsing-remitting MS (RRMS) is characterized by clearly defined attacks of new or increasing neurologic symptoms.
3. Primary Progressive MS (PPMS) worsening neurologic function (accumulation of disability) from the onset of symptoms, without early relapses or remissions.
4. Secondary Progressive MS (SPMS) Most people who are diagnosed with RRMS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time.
The History
In the past 20 years, we’ve seen a lot of improvement in the battle against MS to benefit the 2.3 million people worldwide who have this ailment. Notwithstanding these developments, people with RMS continue to need medications that offer the possibility for greater efficacy than standard-of-care interferons, with a favorable safety profile.
For people with PPMS there were no approved treatments before Ocrevus. Previous Phase III trials with investigational medicines have been unsuccessful in demonstrating a significant effect on disability progression in PPMS.
What is the science behind it?
Ocrevus
- targets myelin-attacking B-cells (unlike similar medications attacking T-cells)
- is an anti-CD20 humanized monoclonal antibody
How was the drug developed?
Genentech’s Medical Director, Peter Chin, said “The journey of ocrelizumab in MS started about 15 years ago, when Genentech began collaborating with academic researchers at major universities to investigate the importance of B cells in MS and their potential as a therapeutic target. The first small proof-of-concept studies showed that CD20+ B cells appeared to play a more important role in MS than anybody previously thought.”
Read the full interview with Genentech’s Peter Chin here
* #ThursdayThought from our Founder @NDavisR Beyond excited FDA approves #Ocrevus by @genentech 4 RelapsingPrimary Progressive MS! #EraseMS pic.twitter.com/WchaPkTIvn
— Race to Erase MS (@RacetoEraseMS) March 30, 2017
What was the outcome of the trials?
More than 1,600 MS patients enrolled in clinical trials for Ocrevus and 94 percent of participants had fewer brain lesions during the 96 weeks of treatment.
Prof Gavin Giovannoni involved in trials for new drug that alters the immune system; a "landmark" in treating MS. #Ocrelizumab pic.twitter.com/aNCzqHI6y1
— Blizard Institute (@blizard_inst) January 20, 2017
A summary of the data from the OPERA I, OPERA II and ORATORIO studies that support this approval can be found here.
What are some of the doubts?
There was little increased risk of infection (link).
The clinical trials for Ocrevus also found that while patients taking the drug did have a slightly increased risk of common colds and flu, they had no significant increased risk of other infections when compared to patients taking the alternative medication, Rebif.
Some concerns like “Targeting B cells in MS patients appears to be Ocrevus’ strength, but depleting B cells also raises safety concerns” were addressed to Dr Chin. He responded saying, “Ocrelizumab selectively binds to CD20, a cell surface antigen expressed by a subset of B cells. CD20 is not expressed on stem cells or antibody-producing plasma cells, and therefore pre-existing humoral immunity and the ability to reconstitute B cells may be preserved. Since the CD20 protein is not found on many other cells of the immune system, they can continue to fight infection and other illnesses.
What should the patients and their families know?
Ocrevus
- will be administered by intravenous infusion every six months.
- will be used for treating primary progressive MS.
- will also be used for treating relapsing MS patients.
- may have potential serious side effects which may include infusion reactions, infections and malignancies where only routine screening is required based on age and medical history
Medness Quotient from Imit Kaur:
“Analysts forecast annual sales exceeding $3 billion by 2021 as reported by Reuters. After the approval news, Biogen stock fell by 2%, and Roche stock rose by a fraction. Novartis’s drug for MS treatment, BAF312, for secondary progressive MS is expected to receive regulatory approval in the first half of 2017. Until then, Roche can bask in glory (Reuters, Investor’s Business Daily, FiercePharma).”
Featured image source: Pixabay
References:
- https://www.gene.com/media/press-releases/14657/2017-03-28/fda-approves-genentechs-ocrevus-ocrelizu?platform=hootsuite
- http://www.nationalmssociety.org/What-is-MS/Types-of-MS
- https://multiplesclerosisnewstoday.com/2017/02/28/transcript-of-interview-with-genentech-peter-chin-on-ocrevus-for-multiple-sclerosis/
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