Newbury Pharmaceuticals is pleased to announce the successful Marketing Authorization (MA) of Tofacitinib Newbury 5 mg and 10 mg film-coated tablets in Sweden as the first country in a Scandinavian registration procedure. Approvals in Norway and Denmark are expected to follow upon finalized national reviews.
Tofacitinib Newbury, an oral Janus kinase (JAK) inhibitor, is a medication for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis. Tofacitinib Newbury is a generic version of Xeljanz. The current annual value of the Scandinavian market is estimated to be 19.3 MEUR according to DLMI Nordic Pharma Insights. This approval marks Newbury's entry into the immunology therapeutic area, complementing its existing focus on oncology, rare diseases and neurology, and reflects the company's ambition to broaden treatment access across the Nordic region.
“Tofacitinib Newbury represents an important step for us into a new therapeutic area. Immunology and rheumatology are fields with significant unmet need for affordable treatment options, and this approval reflects our ambition to broaden Newbury's footprint across therapeutic areas in the Nordics. We look forward to bringing this treatment to patients as soon as regulatory exclusivities and patents allow us.” says Mr Karl Karlsson CEO of Newbury