Roche/Genentech’s Ocrevus has been approved by the US Food and Drug Administration to treat both relapsing and primary progressive forms of multiple sclerosis.
Ocrevus (ocrelizumab) is first-in-class, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal (nerve cell) damage, which can lead to disability in people with MS.
The green light came on the back of data from the OPERA I and OPERA II Phase III trials involving patients with relapsing MS, which affects around 85 percent of people at time of diagnosis, which found that the drug beat Rebif (interferon beta-1a) in reducing the three major markers of disease activity over a two-year period.
The trials showed a 46 percent and 47 percent reduction in the annualised relapse rate, as well as a 43 percent and 37 percent risk reduction in confirmed disability progression for 12 weeks compared with interferon beta-1a.
Clearance was also based on findings of the Phase III ORATORIO trial in people with primary progressive MS, a form of the disease marked by steadily worsening symptoms for which there is no approved treatment, in which the biologic significantly slashed the progression of clinical disability by 24 percent versus a for at least 12 weeks (the primary endpoint), and by 25 percent over 24 weeks (a secondary endpoint).
Ocrevus is now the first and only approved treatment for primary progressive MS (PPMS). According to Roche, the fact that efficacy has been shown across both forms of condition "validates the hypothesis that B cells are central to the underlying biology of the disease".
The US approval of the drug “is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy,” said Sandra Horning, chief medical officer and head of Global Product Development.
“Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe Ocrevus, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”
Meanwhile, the FDA also waved through approved Sanofi’s Dupixent (dupilumab) as the first and only targeted biologic medicine for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. In the US, it is estimated that 300,000 people with moderate-to-severe AD remain uncontrolled despite their current treatment and are most in need of new treatment options.
To date, the condition has been treated with topical corticosteroids and broad immunosuppressants which affect only the skin symptoms or dampen the activity of the entire immune system, which can have numerous side effects.
Dupixent is a human monoclonal antibody that offers a different approach by specifically inhibiting overactive signalling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD.
"People with moderate-to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," said Julie Block, president and chief executive of the National Eczema Association.
"To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease…Now we have a treatment that is expected to help address patients suffering from this devastating disease."