What's Happening?
GSK has received approval from China's National Medical Products Administration for its drug Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease
(COPD) characterized by raised blood eosinophils. This approval marks a significant milestone for GSK, as China accounts for approximately a quarter of the global COPD patient population. Nucala, already approved for severe asthma and other eosinophilic inflammation conditions, is the first monthly biologic approved in China for a broad COPD population with a blood eosinophil count starting as low as 150 cells/µL. The approval comes amidst China's efforts to enhance screening and treatment capacity for COPD, a priority within the government's Healthy China 2030 public health plan.
Why It's Important?
The approval of Nucala in China is crucial due to the high incidence and mortality rate of COPD in the country, which surpasses global averages. This development provides a novel treatment option for patients, potentially reducing exacerbations that lead to emergency department visits and hospitalizations, thereby lowering annual direct medical costs. GSK anticipates that Nucala's less frequent dosing and broader label will make it a competitive option against existing treatments like Sanofi and Regeneron's Dupixent. The approval is expected to significantly boost GSK's sales, with COPD potentially adding £500 million to its peak sales potential.
What's Next?
Following the approval in China, GSK is pursuing regulatory submissions for Nucala in COPD in Europe and other regions. The company aims to capitalize on the drug's unique dosing schedule and broad applicability to expand its market presence. As China continues to enhance its healthcare infrastructure, GSK's Nucala could play a pivotal role in addressing the unmet needs of COPD patients, potentially influencing treatment protocols and healthcare policies.
