BeiGene Announces Acceptance by Swissmedic of Marketing Authorization Application for BRUKINSA® (Zanubrutinib) in Waldenström’s Macroglobulinaemia
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenstrms macroglobulinaemia (WM).
- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenstrms macroglobulinaemia (WM).
- Gerwin Winter, Senior Vice President, Head of Commercial, Europe, at BeiGene said: The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM.
- The approval by Swissmedic would grant marketing authorization for BRUKINSA in WM within Switzerland.
- Treatment and outcome patterns in European patients with Waldenstrms macroglobulinaemia: a large, observational, retrospective chart review.