GlaxoSmithKline plc recently received Food and Drug Administration (FDA) approval for Nucala (mepolizumab) to target a form of vasculitis called eosinophilic granulomatosis with polyangiitis (EGPA).
The condition, previously known as Churg-Strauss syndrome, is a rare systemic inflammation of blood vessel walls. GSK previously submitted a supplemental biologics license application (sBLA) for mepolizumab in June, a company release said.
The treatment, an interleukin-5 (IL-5) antagonist, resulted from a yearlong Phase III study conducted jointly by GSK and the National Institute of Allergy and Infectious Diseases (NIAID), which operates under the auspices of the National Institutes for Health. The research analyzed the efficacy and safety for a 300 mg dose of the substance given subcutaneously in 136 patients.
Nucala is now available in the U.S., according to the release. Originally used to treat specific types of asthma, mepolizumab was developed to treat certain inflammation-related diseases
University of Pennsylvania’s Dr. Peter Merkel, chief of rheumatology at Perelman School of Medicine, and Denver-based National Jewish Health Center’s professor of medicine Dr. Mike Wechsler anchored the study and consulted with GSK. Merkel observed that EGPA patients struggle with diagnostic delays, limited treatment choices, while Wechsler said many frequently relapse.
“Rheumatologists, immunologists, and pulmonologists have an important role in properly diagnosing and treating patients with EGPA,” Merkel said. The “approval of mepolizumab provides specialists with the ability to offer a targeted treatment to appropriate patients with this complex disease.”