Adults with generalized myasthenia gravis (gMG) have yet another therapeutic option, this time from UCB SA, with the U.S. FDA’s approval of orphan drug Rystiggo (rozanolixizumab-noli), a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor.
UCB SA has identified imidazotriazine derivatives acting as IL-17 modulators reported to be useful for the treatment of autoimmune and inflammatory disorders.
Novartis AG rolled out positive phase III data Sept. 13 with Cosentyx (secukinumab), its interleukin-17A (IL-17A) inhibitor for hidradenitis suppurativa, offering more evidence for the approach taken up by a handful of biopharma firms.
UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis.
Zogenix Inc.’s Fintepla (fenfluramine) cleared the U.S. FDA hurdle shortly after its March 25 PDUFA date, expanding the drug’s use in patients with Lennox-Gastaut syndrome (LGS) and validating UCB SA’s $1.9 billion acquisition of Emeryville, Calif.-based firm, which closed earlier this month.
Moonlake Therapeutics AG is making headway on its mission to establish a broad dermatology and rheumatology franchise around its sole product, sonelokimab, announcing it is poised to start a phase II study in hidradenitis suppurativa.
Brightinsight Inc. and UCB SA struck a deal to jointly develop a digital disease management solution for patients with rare diseases. The companies will start with a mobile app for myasthenia gravis (MG) built on Brightinsight’s platform. UCB joins CSL Behring, Novo Nordisk A/S, Sanofi SA and Roche AG in partnering with Brightinsight on digital disease management.
UCB SA anticipates submitting regulatory applications in the third quarter for IL-17-targeting bimekizumab in psoriatic arthritis and ankylosing spondylitis, after chalking up second successful phase III trials in both indications. Meanwhile, the high commercial hopes for the would-be blockbuster remain at least temporarily deferred as pandemic-related travel restrictions have delayed FDA action on the BLA for plaque psoriasis.
UCB SA has unveiled plans to acquire Zogenix Inc. in a deal worth up to $1.9 billion (€1.7 billion), adding to its portfolio an approved drug aimed at rare forms of epilepsy. Brussels-based UCB will pay $26 per share in cash for the Emeryville, Calif.-based biotech, plus a contingent value right of $2 per share, which would pay out upon approval of the oral drug Fintepla (fenfluramine) for Lennox-Gastaut syndrome.
