3rd Jan 2025 08:21
(Alliance News) - GSK PLC on Friday reported that its Nucala treatment has been approved in China to treat long-term sufferers of a sinus ailment following a phase 3 study.
The London-based pharmaceuticals firm said Nucala, also known as mepolizumab, was green lit by the China National Medical Products Administration for the treatment of adults with chronic rhinosinusitis with nasal polyps.
This approval follows a positive phase 3 trial analysing mepolizumab over 52 weeks versus placebo in a group of 163 Russian, Chinese and Japanese patients with "inadequately controlled CRSwNP". Results from the study showcased that mepolizumab "significantly improved nasal obstruction visual analogue scale score" and was tied to a reduction in nasal polyp score at the end of the study.
There are approximately 107 million sufferers of chronic sinusitis in China, with around 30 million having CRSwNP. The ailment exhibits symptoms including loss of smell, breathing problems and sleep disturbance.
Surgery is an option for sufferers of the condition, but GSK noted that flare-ups may yet occur. "Although surgery can be effective at removing polyps, the underlying type 2 inflammation means they have a tendency to regrow," the firm said.
GSK Global Head of Respiratory/Immunology R&D Kaivan Khavandi 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."
Shares in GSK were up 0.3% at 1,365.00 pence on Friday morning in London.
By Christopher Ward, Alliance News reporter
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