This year has been extremely gratifying, with key milestones reached towards our aspiration to become the patient-preferred biopharma leader.
In 2019, UCB launched 2 new products – Evenity® and Nayzilam® – and obtained new approvals for treatments in both our specialty areas of neurology and immunology – including new approvals for Cimzia®. We also progressed our pipeline as planned. These successes confirm the relevance of our Strategy and put us in a strong position to continue our growth journey.
The U.S. Food and Drug Administration (FDA) granted approval for Cimzia® as the first medicine for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA).
UCB and its partner Amgen obtained approval for Evenity®, a sclerostin inhibitor to treat osteoporosis in those at high risk of fracture, in Japan, the U.S. and Europe.
Nayzilam®1 was the first FDA approved nasal spray rescue treatment for seizure clusters.
bimekizumab positive results were confirmed in three Phase 3 psoriasis studies. The application for approval of bimekizumab to treat adults with moderate-to-severe plaque psoriasis is planned in mid-2020.
The Phase 3 development study of rozanolixizumab in patients with myasthenia gravis (MG) started in June 20192 as planned, confirming UCB’s decision to accelerate the development of our novel sub-cutaneous anti-FcRn.
UCB agreed to acquire Ra Pharmaceuticals. Through this acquisition our objective is to improve treatment options for people living with myasthenia gravis and other rare diseases. This merger was approved by Ra Pharmaceuticals shareholders in December 2019. However, it remains subject to antitrust clearances and other customary closing conditions. We expect to receive those clearances and close the transaction in the first quarter of 2020.
1 Nayzilam® (midazolam) nasal spray CIV U.S. Prescribing Information https://www.ucb-usa.com/_up/ucb_usa_com_kopie/documents/Nayzilam_PI.pdf.
2 https://clinicaltrials.gov/ct2/show/NCT03971422, accessed on 18 January 2019.