Category: Myasthenia Gravis

UCB announces European Commission approval of ZILBRYSQ[®]▼ (zilucoplan)  4th December, 2023: UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted a marketing authorisation for ZILBRYSQ® (zilucoplan) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.1  Zilucoplan is the…

UCB receives CHMP positive opinion for rozanolixizumab for treatment of adults with generalized myasthenia gravis in Europe 10th November 2023; UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorisation for rozanolixizumab as an add-on to standard therapy…

UCB receives CHMP positive opinion of zilucoplan for the treatment of adults with generalised myasthenia gravis in Europe 15 September 2023 – UCB, a global biopharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorisation for…

FDA acceptance of new drug application and EMA MAA validation On 14th November 2022, UCB announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its investigational treatment, zilucoplan.  Zilucoplan is a subcutaneous (SC), self-administered peptide inhibitor of complement component 5 (C5 inhibitor) for the treatment…

Positive topline results from UCB MycarinG study investigating the efficacy and safety of rozanolixizumab in patients with generalised myasthenia gravis (gMG) Study met primary and all secondary endpoints with statistical significance Rozanolixizumab was well tolerated with no new observed safety signals  UCB plans regulatory submissions for rozanolixizumab in gMG from Q3 2022  December 10th, 2021…