GSK's (GSK.US) new drug Demodex mite infection has been accepted for a new indication, marking another milestone in the company's ongoing efforts to expand the therapeutic options available to patients.
1min read On January 4, the National Medical Products Administration's Center for Drug Evaluation and Research (CDE) officially announced that the new application for the new drug depemokimab (GSK.US) submitted by GlaxoSmithKline (GSK) for a new indication was accepted. The first application for the drug was accepted by the CDE on January 1 this year.According to GSK's public information, depemokimab (GSK3511294) is a long-acting IL-5 inhibitor with an extended half-life, which is expected to control patients' symptoms by being administered every six months. The product has achieved positive results in four Phase 3 clinical studies for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), and the results of these four trials will be used to support the regulatory submissions in the global range.According to the official website of the China Drug Clinical Trial Registration and Information Disclosure Platform, GlaxoSmithKline has conducted several Phase 3 clinical studies of depemokimab in China, including a Phase 3 clinical study for the treatment of severe uncontrolled asthma in adults and adolescents with eosinophilic granulocyte phenotype, and two Phase 3 clinical studies for CRSwNP have completed recruitment. In the study, depemokimab was administered subcutaneously every six months or every 26 weeks.