China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Arcalyst (rilonacept), a treatment for recurrent pericarditis (RP). This marks an expansion of the drug’s application in addressing autoimmune diseases.
Rilonacept’s Mechanism and Global Approvals
Rilonacept is a recombinant dimer fusion protein that blocks interleukin-1 α (IL-1 α) and interleukin-1 β (IL-1 β) signal transduction. Originated by Regeneron Pharmaceuticals Inc., it was approved for marketing in the United States in 2008 to treat cryo-pyrin-associated periodic syndromes (CAPSs). The molecule gained further approval to treat IL-1 receptor antagonist deficiency (DIRA) in the US in 2020. Kiniksa Pharmaceuticals Ltd (Nasdaq: KNSA) obtained the license to the drug in 2017, which was awarded breakthrough therapy designation (BTD) for use in RP in the US in 2019. Orphan drug designations (ODDs) were awarded in the US and Europe in 2020 for the treatment of pericarditis and idiopathic pericarditis, respectively.
Huadong Medicine’s Licensing Deal and Regional Rights
Huadong Medicine secured a USD 662 million licensing deal with Kiniksa in 2022, taking exclusive development, regulatory filing, and commercialization rights to rilonacept along with mavrilimumab, both therapies for autoimmune diseases, in China, South Korea, and other regions.
Rilonacept’s Recent Approvals in China
Rilonacept was first approved in China last month for the treatment of CAPSs, including familial cold autoimmune syndrome (FCAS) and muckle-well syndrome (MWS). The latest approval for recurrent pericarditis further expands the drug’s potential patient base and underscores Huadong Medicine’s commitment to bringing innovative treatments to market.-Fineline Info & Tech
