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  • Rozanolixizumab has been designated as an orphan drug
  • by Eo, Yun-Ho | translator Kim, Jung-Ju | Jun 14, 2023 05:37am
Ministry of Food and Drug Safety recognized innovativeness of drug targeting Fc receptor
Hanall, Johnson & Johnson, etc. are close to the commercialization of candidate materials
Rozanolixizumab, a new drug for generalized myasthenia gravis, has been designated as an orphan drug.

The Ministry of Food and Drug Safety recently announced that it designated UCB's gMG treatment Rozanolixizumab as an orphan drug. The target indication is the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive and require additional therapy with corticosteroids or non-steroidal immunosuppressants. This drug was designated for expedited review by the U.S. FDA in January and is currently undergoing approval procedures in Japan. Rozanolixizumab is a type of monoclonal antibody for subcutaneous injection that targets the e
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