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 The infusible drug, known chemically as ocrelizumab, becomes the
first U.S.-approved medicine for the primary progressive form of the
neurological disease (PPMS). It is also approved to treat the most
common form of the disease, known as relapsing-remitting multiple
sclerosis (RRMS).
Roche said Ocrevus will be available to people in the United States
within two weeks.
The drug's entry into the U.S. market was delayed by three months
when the FDA in late December pushed back its deadline for an
approval decision, saying the commercial manufacturing process for
Ocrevus was not yet ready.
Ocrevus, an immunosuppressive drug that reduces the immune system's
assault on the body's own neurons, could become a mainstay treatment
for MS and help offset falling revenue from Roche's top-selling
cancer drugs Rituxan, Avastin and Herceptin, that will soon face
competition from cheaper biosimilar versions.
Analysts forecast annual sales exceeding $3 billion by 2021,
according to Reuters data.
Roche rival Novartis AG is also developing its own MS treatment,
BAF312, for secondary progressive multiple sclerosis. It could file
for regulatory approval in the first half of 2017, Novartis has
said, although the official filing target for BAF312 remains 2019.
Other companies are also seeking new drug alternatives for different
forms of MS, including GeNeuro SA.
The most popular MS treatment in the United States currently is
Copaxone, made by Teva Pharmaceuticals Industries Ltd.
Roche said in the PPMS study that patients who took Ocrevus were 47
percent more likely than those who received a placebo to show no
evidence of disease progression.
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The company said its trials among RRMS patients showed 75 percent
more patients reached "no evidence of disease activity" status when
taking Ocrevus compared with those using Merck & Co Inc's Rebif, an
older therapy.
The drug's path to approval has not been straightforward.
In 2010, Roche and Biogen Inc suspended trials of the biotech
medicine against rheumatoid arthritis after patients died from fatal
opportunistic infections. Trials were also suspended for lupus
nephritis patients. <reut.rs/2gJfDIp>
Against multiple sclerosis, however, Roche has said the fatal side
effect was not repeated. Infusion-related reactions were among the
main adverse side effects seen in MS trials.
(This version of the story corrects seventh paragraph to show
Novartis could file BAF312 with regulators in H1 2017, from expects
H1 2017 approval)
(Reporting by John Miller in Zurich and Akankshita Mukhopadhyay in
Bengaluru; Additional reporting by Bill Berkrot in New York; Editing
by Lisa Shumaker and Bill Rigby)
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