The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023 and US giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Tremfya (guselkumab) are on course to obtain breakthrough therapy designations (BTDs). LNP023 is to be awarded BTD status for its use in paroxysmal nocturnal hemoglobinuria (PNH), while Tremfya’s award is to treat moderate to severe active Crohn’s disease (CD).
LNP023: First-in-Class Complement Factor B Inhibitor
LNP023, a first-in-class oral complement factor B inhibitor, is under development to treat PNH and a variety of renal diseases with complement system involvement and serious unmet needs. These include IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome, and membranous nephropathy. The drug has been awarded orphan drug designations (ODDs) in the US and European Union for use in PNH and C3G, and was granted BTD status in China targeting C3G in March 2022.
Tremfya: IL-23 Monoclonal Antibody for Autoimmune Diseases
Tremfya, an IL-23 monoclonal antibody, is used to treat multiple autoimmune diseases. First approved for marketing in the US in July 2017, it was subsequently approved in Hong Kong in November 2018 and in mainland China in December 2019 with priority review status among the first batch of clinically urgent overseas drugs to treat psoriasis. In terms of Crohn’s disease, Tremfya is currently subject to a Phase III clinical study, having yielded positive data in the Phase II GALAXI1 study for moderate to severe CD.
Strategic Implications
The potential BTDs for LNP023 and Tremfya highlight the significant progress these drugs are making in their respective therapeutic areas. For Novartis, LNP023’s BTD status for PNH and its existing designations for renal diseases underscore the drug’s potential to address serious unmet medical needs. For Janssen, Tremfya’s expansion into Crohn’s disease treatment, supported by positive clinical data, positions the drug to potentially improve outcomes for patients with this challenging condition. These developments are expected to enhance the market prospects for both drugs and further solidify the companies’ positions in the global pharmaceutical market.-Fineline Info & Tech
