FDA
gives ocrelizumab breakthrough designation for PPMS:
Roche
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[February 17, 2016]
ZURICH (Reuters) - The U.S. Food and
Drug Administration has granted breakthrough therapy designation for
ocrelizumab (OCREVUSTM) for treating people with primary progressive
multiple sclerosis (PPMS), Swiss drugmaker Roche said on Wednesday.
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There are no approved treatments now for PPMS, a debilitating form
of the disease marked by steadily worsening symptoms.
"Roche plans to pursue marketing authorization for both PPMS and
relapsing multiple sclerosis (RMS), a more common form of the
disease, and will submit data from three pivotal Phase III studies
to global regulatory authorities in the first half of 2016," it said
in a statement.
Roche believes ocrelizumab's potency and benign side effect profile
make it unique, while industry analysts see it as a likely
multibillion-dollar-a-year seller that will help the group diversify
beyond its mainstay cancer business.
Breakthrough therapy designation expedites the development and
review of medicines intended to treat serious or life-threatening
diseases. Ocrelizumab is the first investigational medicine for MS
to win the designation by the FDA, Roche said.
Clinical trials released in October showed Roche's big new drug hope
cut multiple sclerosis relapses by nearly half compared with the
older product Rebif, underscoring its potential in the main
relapsing form of the disease.
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Ocrelizumab also cut clinical disability by nearly a quarter in a
separate study of people with PPMS, which affects around 15 percent
of patients.
(Reporting by Michael Shields; Editing by Joshua Franklin)
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