On This Day in Health: March 28, 2017
On March 28, 2017, the United States Food and Drug Administration approved ocrelizumab, marketed as Ocrevus, for adults with relapsing forms of multiple sclerosis and with primary progressive multiple sclerosis. It was the first FDA-approved medicine for the primary progressive form. The decision gave a previously underserved group an authorized disease-modifying treatment and added another option for relapsing disease. Although some coverage appeared the next day, the original approval record establishes March 28 as the anniversary. The milestone concerned the intravenous medicine, distinct from formulations developed and authorized in later years.
Multiple sclerosis involves damage within the central nervous system, including injury to the protective covering around nerve fibers. Relapsing disease and primary progressive disease have different clinical patterns, making separate study designs important. Ocrelizumab is an antibody directed against CD20, a marker on certain B cells. Its development reflected growing attention to the role of those immune cells in the disease. The treatment approach did not rebuild damaged nerves or provide a cure. It sought to change disease activity and progression through a defined immune target, with clinical outcomes needed to demonstrate the effect.
The approval was supported by three major trials. OPERA I and OPERA II studied relapsing disease and compared ocrelizumab with interferon beta-1a. ORATORIO studied primary progressive disease and compared it with placebo. The studies examined outcomes including relapses, disability progression, and brain imaging findings, with different questions appropriate to each population. The primary progressive trial found a reduction in confirmed disability progression relative to placebo. That result meant a difference in the risk of worsening across groups, rather than an end to progression for every participant. Preserving that distinction helps explain why the authorization mattered without overstating its effect.
The regulatory framework also addressed infusion reactions and infections, among other risks associated with treatment. A new immune-directed medicine required attention to benefit, tolerability, and monitoring together. March 28 represents a notable expansion of care because it brought controlled-trial evidence into a form of multiple sclerosis that had lacked an approved option. The event also illustrates the value of distinguishing disease subtypes in research rather than assuming that one study answers every clinical question. Its lasting significance lies in the first authorization for primary progressive disease and in the work that connected an immune-cell target with patient outcomes. For the history of neurological treatment, it is a milestone of measurable progress within a complex chronic condition, while rehabilitation, support, and further research remained important parts of care.
The effective approval date was March 28, 2017. Some news announcements appeared the following day.
The decision included primary progressive multiple sclerosis. It was the first FDA-approved medicine for that form.
Ocrelizumab targets CD20 on certain B cells. It does not rebuild damaged nerves or cure MS.
OPERA I and II studied relapsing disease. Their comparator was interferon beta-1a.
ORATORIO studied primary progressive disease against placebo. It measured confirmed disability progression among other outcomes.
A reduction in progression risk is not an end to all worsening. Treatment benefit and adverse effects required assessment together.
Explore more of "On This Day ..."
Discover more events from the same date across news, politics, technology, sports, and other fields. Each link highlights significant moments that shaped history on different fronts.