Swedish pharmaceutical company Newbury Pharmaceuticals AB (STO:NEWBRY) announced on Monday that it has received marketing authorisation in Sweden for Tofacitinib Newbury 5 mg and 10 mg film-coated tablets, marking the first approval in a Scandinavian registration procedure.
Approvals in Norway and Denmark are expected following the completion of national reviews.
Tofacitinib Newbury, an oral Janus kinase (JAK) inhibitor, is a generic version of Xeljanz and is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis. Newbury said the approval marks its entry into the immunology market, complementing its oncology, rare diseases and neurology portfolio, while targeting a Scandinavian market estimated at EUR19.3m annually.
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