GlaxoSmithKline’s Nucala may soon get some serious competition in the severe asthma market from an AstraZeneca rival. So the British drugmaker is setting out to see how Nucala fares in other diseases, too.
GSK said Tuesday it had started up a phase 3 study of Nucala in patients with severe nasal polyps, a chronic inflammatory disease that can cause symptoms such as facial pain, breathing problems and loss of smell.
While polyps aren’t life-threatening, they are common. And if successful, Nucala could provide an alternative to the corticosteroids that are the current standard of care and possibly prevent the surgeries severe cases sometimes require.
If successful, the trial could lead to a nasal polyps approval, boosting the med outside of the eosinophilic asthma arena. That's a field that could soon get crowded. Right now, Glaxo is battling Teva’s Cinqair, though as an intravenous med, the Israeli drugmaker’s product is less convenient than Nucala, which is an injectable.
AstraZeneca's injectable candidate benralizumab, however, could prove a greater threat. Evidence may support dosing the AZ med at eight-week intervals, instead of the every-four-weeks schedule for Nucala.
GSK doesn’t seem worried, though; it’s “very pleased with the progress” of Nucala so far, CEO Emma Walmsley said druing April’s first-quarter earnings call. More than 10,000 patients in the U.S. are treated with the drug, and Nucala has grown the severe asthma market by a third, she pointed out.
That doesn’t mean the company is ready to rest on Nucala’s laurels. In addition to the nasal polyp trial, which is set to wrap in 2019, Glaxo is also conducting phase 3 Nucala trials in chronic obstructive pulmonary disease (COPD), the autoimmune condition Churg-Strauss syndrome, and severe hypereosinophilic syndrome. Nucala is also in phase 2 as a treatment for serious cases of the skin condition atopic dermatitis, also known as eczema.