Positive Phase III trial results from UCB’s two clinical trials in its generalized myasthenia gravis (gMG) program will enable it to become a key future player in the MG market, with both zilucoplan and rozanolixizumab expected to enter the market next year, says GlobalData, a leading data and analytics company.

Philippa Salter, Neurology Analyst at GlobalData, comments: “MG is a rare autoimmune and neuromuscular disease that is characterized by muscle weakness and fatigue. The MG market is one of high potential for drug developers, as seen through the high sales revenue of AstraZeneca’s Soliris. GlobalData forecasts peak global (7MM*) sales of $1.4 billion for Soliris in 2027 in this indication. Additionally, there is high unmet need in the MG market, particularly for more effective therapies for refractory or difficult to treat diseases, and as such it is becoming increasingly competitive with more companies looking to become key players.”

If approved, UCB’s zilucoplan would be the third complement C5 inhibitor on the market for the treatment of MG and will face significant competition from Soliris (eculizumab), the current market leader, and Ultomiris (ravulizumab-cwvz), only recently approved by the FDA for MG in April 2022.

Salter continues: “To be competitive, UCB is looking to differentiate zilucoplan through its route of administration. While both Soliris and Ultomiris are administered via intravenous infusion by a healthcare professional, zilucoplan can be self-administered via a subcutaneous injection. However, although self-administration can be more convenient for patients than regular infusion center visits, zilucoplan requires daily administration, whereas Soliris requires administration once every two weeks and Ultomiris only once every eight weeks. The long-acting nature and convenient administration schedule of Ultomiris is expected to be a game-changer for MG patients.”

UCB’s second drug, rozanolixizumab, is a FcRn-antagonist, and, if approved, will face competition from Argenx’s Vyvgart (efgartigimod alfa), a monoclonal antibody (mAb) with the same mechanism of action, which was approved by the FDA in 2021.

Argenx is already looking to strengthen Vyvgart’s position in the MG market with plans to file for a subcutaneous formulation later in 2022, complementing the already approved intravenous formulation and enabling greater penetration of the MG market. Competition within the anti-FcRn mAb class is set to increase further with Johnson & Johnson’s nipocalimab in Phase III trials and HanAll Biopharma/ ImmunoVent’s batoclimab expected to enter into Phase III pivotal trials in the near future.

Salter concludes: “AstraZeneca recently became the market leader in MG through its acquisition of Alexion Pharmaceuticals, which was completed in July 2021. However, with the US patent expiry of Soliris expected in 2027, and the entry of new products into the MG market over the next few years, it is unlikely that AstraZeneca will remain the only major player in the market.”

*Seven major markets = US, France, Germany, Italy, Spain, UK, and Japan