The US Food and Drug Administration yesterday expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body.
This new indication for UK pharma major GlaxoSmithKline’s (LSE: GSK) Nucala provides the first FDA-approved therapy specifically to treat EGPA. GSK’s shares closed up 0.8% in late trading on Tuesday at 1,314.00 pence.
According to the National Institutes of Health, EGPA (formerly known as Churg-Strauss syndrome) is a condition characterized by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small- to medium-sized blood vessels. The inflamed vessels can affect various organ systems including the lungs, gastrointestinal tract, skin, heart and nervous system. It is estimated that approximately 0.11 to 2.66 new cases per 1 million people are diagnosed each year, with an overall prevalence of 10.7 to 14 per 1,000,000 adults.
“Prior to today’s action, patients with this challenging, rare disease did not have an FDA-approved treatment option,” said Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, adding: “The expanded indication of Nucala meets a critical, unmet need for EGPA patients. It’s notable that patients taking Nucala in clinical trials reported a significant improvement in their symptoms.”
Eric Dube, senior vice president and head of GSK Global Respiratory Franchise, said: “Following physician and patient experience with Nucala in severe eosinophilic asthma, we are thrilled that the FDA has expanded the use of this medicine to patients with EGPA, another eosinophil-driven disease, enabling GSK to make it available to patients. This approval follows the positive results of the largest prospective treatment study conducted in EGPA to date, and now for the first time physicians have a targeted treatment option for this debilitating condition.”
Mepolizumab 100mg is approved for the treatment of patients with severe eosinophilic asthma in over 40 countries including the European Union, USA, and Japan and has been prescribed to over 18,000 patients in the USA. Nucala was first approved in 2015 for severe eosinophilic asthma and the company submitted a supplemental application in June 2017, to expand the use of the medicine.
Nucala for treatment of EGPA in the USA is available now, the drugmaker said. In recognition of the fact that US consumers are increasingly being asked by their insurers to take on more cost sharing, making affordability a concern for some patients, GSK has various patient assistance programmes available for those who qualify.
Just last month, Anglo-Swedish rival AstraZeneca’s (LSE: AZN) Fasenra (benralizumab) gained FDA approval for the treatment of severe eosinophilic asthma, and analysts have said that its less frequent dosing is a potential advantage. Last month GSK also filed for approval to market mepolizumab for the treatment of eosinophilic chronic obstructive pulmonary disease (COPD) in the USA.