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CORRECTED-Roche MS drug Ocrevus approved by FDA after 3-month delay
2017年3月29日 / 凌晨12点54分 / 8 个月前

CORRECTED-Roche MS drug Ocrevus approved by FDA after 3-month delay

(Corrects paragraph 2 to say the drug is infusible, not injectable)

March 28 (Reuters) - The U.S. Food and Drug Administration (FDA) on Tuesday approved Roche Holding AG’s multiple sclerosis (MS) drug Ocrevus, putting the potential blockbuster drug back on track after a delay by regulators over manufacturing issues.

The infusible drug, known chemically as ocrelizumab becomes the first U.S. approved medicine for primary progressive form of the neurological disease (PPMS).

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 a decision, saying the commercial manufacturing process for Ocrevus was not yet ready. (Reporting by Akankshita Mukhopadhyay in Bengaluru and John Miller in Zurich; additional reporting by Bill Berkrot in New York; Editing by Lisa Shumaker)

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