Zai Lab obtains BTD for efgartigimod alfa injection

Zai Lab announced that the Center for Drug Evaluation, CDE, of the National Medical Products Administration, NMPA, granted Breakthrough Therapy Designation for efgartigimod alfa injection for the treatment of patients with chronic inflammatory demyelinating polyneuropathy, CIDP. The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study. “In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of efgartigimod SC as an innovative treatment option for CIDP patients,” said Dr. Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “We have seen how efgartigimod SC can meaningfully improve and stabilize disease symptoms in these patients. Existing treatment options are quite limited, and problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy. In the ADHERE study, significant efficacy was demonstrated with a favorable safety profile. We are excited about the therapeutic potential of efgartigimod SC in CIDP, and we look forward to working with regulatory authorities in China to bring this important medicine to patients in need as soon as possible.”