- China approval for Nucula
- Third indication achieved in China
- Nucula has generated £1.3 billion of sales year-to-date
Pharmaceutical firm GSK (GSK) said it has received approval from the China Medical Products Administration for Nucula, its monoclonal antibody treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
It is the third indication to be approved in China for adults with CRSwNP for whom therapy with systematic corticosteroids and or surgery do not provide adequate disease control.
WHAT DID THE COMPANY SAY?
Kaivan Khavandi, GSK’s global head of respiratory and immunology research and development, said: ‘We are delighted that Nucala has been approved in China as a treatment for CRSwNP, a chronic condition for which new and effective treatments are needed.
‘Patients now have a non-surgical option available to them and an alternative to repeated exposure to oral corticosteroids.’
There are an estimated 107 million people in China who suffer from chronic sinusitis, about a third of whom also have nasal polyps. Symptoms include nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge, which can significantly affect emotional and physical wellbeing.
Nucula is already approved in China as an add-on maintenance treatment for adults and adolescents above 12 years of age suffering from severe eosinophilic asthma as well as for adults with eosinophilic granulomatosis with polyangiitis, a rare immune disorder that causes inflammation of blood vessels.
Today’s approval follows positive results from the late-stage clinical trial MERIT which studied the effectiveness and safety of Nucula over 52 weeks against a placebo in a population of Japanese, Chinese and Russian patients suffering from CRSwNP.
Nucula generated £444 million of revenue for GSK in the third quarter to the end of September, up 12% year on year, equating to £1.3 billion of sales year-to-date.
GSK shares fell 5p or 0.34% to £13.57 and are around 11% lower over the last 12-months compared with a 7% advance in the blue-chip FTSE 100 index.
