UCB Full Year Report 2019 - Seite 2

In October, Keppra (levetiracetam) was approved, in the U.S., for monotherapy in partial onset seizures. The new indication is intended for the use of Keppra as mono-therapy in treatment of partial-onset seizures in patients one month of age and older and with an updated labeling to comply with the Pregnancy and Lactation Labeling Rule. An important driver for this submission was adding patient value, especially for pregnant women or women of childbearing age.

In December, UCB launched Nayzilam (midazolam) Nasal Spray ^CIV, the first and only nasal rescue treatment for seizure clusters in the U.S. Nayzilam nasal spray was approved in the U.S. in May 2019.

Immunology  
In July, Cimzia (certolizumab pegol) was approved in combination with methotrexate for the treatment of moderate to severe, active rheumatoid arthritis in adult patients in China.
In December, Cimzia was approved for the treatment of psoriasis and psoriatic arthritis in Japan.

During the course of the fourth quarter 2019, UCB reported positive results for three Phase 3 studies with bimekizumab in psoriasis:

• In October, the study BE VIVID, evaluating the efficacy and safety of bimekizumab in adults with moderate-to-severe chronic plaque psoriasis met all primary and ranked secondary endpoints, including significantly greater efficacy compared to ustekinumab.
• In November, the study BE READY, evaluating the efficacy and safety of bimekizumab versus placebo in adults with moderate-to-severe chronic plaque psoriasis, met all primary and ranked secondary endpoints.
• In December, the study BE SURE, comparing bimekizumab to adalimumab for the treatment of adults with moderate-to-severe plaque psoriasis, met all co-primary and ranked secondary endpoints, achieving significantly greater efficacy than adalimumab. 

UCB plans to submit applications to regulatory authorities for approval of bimekizumab to treat adults with moderate-to-severe plaque psoriasis in mid-2020.

In addition, based on a positive proof-of-concept study, UCB decided to move into late stage development with bimekizumab in moderate to severe hidradenitis suppurativa (HS), a severe inflammatory skin disease, affecting predominantly women. The Phase 3 program BE HEARD starts in Q1 2020. First headline results are expected in H1 2023.

Evenity (romosozumab) is now approved in Japan, the U.S., South Korea, Canada and Australia as well as in the EU.