Stopwatch starts on reviews of GSK's long-acting asthma drug

Regulators in the EU, China, and Japan have started reviews of GSK's depemokimab, aiming to become the first drug for severe asthma that can be given just twice a year.

The EMA and counterparts in China and Japan are assessing the anti-IL-5 antibody as an add-on maintenance treatment for asthma patients aged 12 and over who have eosinophilic asthma, a form associated with type 2 inflammation, and whose symptoms can't be controlled with medium to high doses of corticosteroids plus another asthma drug.

Simultaneously, the three regulators are also reviewing a second potential indication for depemokimab as an add-on therapy for chronic rhinosinusitis with nasal polyps (CRSwNP).

GSK has said depemokimab is one of the top prospects in its pipeline, with peak sales potential of £3 billion ($3.7 billion) if approved across all its proposed indications.

"Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems," said Kaivan Khavandi, the group's global head of respiratory and immunology R&D.

Depemokimab is a follow-up to GSK's Nucala (mepolizumab), a once-monthly IL-5 inhibitor approved for severe asthma, CRSwNP, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES) that made sales of £1.3 billion in the first nine months of 2024 and is one of the company's top products.

It is one of five key product launches that GSK is hoping to make this year along with Nucala for chronic obstructive pulmonary disorder (COPD), novel antibiotic gepotidacin, new MenABCWY meningitis vaccine, and the relaunch of cancer drug Blenrep (belantamab mafodotin).

In the SWIFT-1 and SWIFT-2 trials, depemokimab achieved a 72% reduction in clinically significant exacerbations that required hospitalisation or a visit to an emergency room, although, the drug missed the mark on some other endpoints, including lung function, asthma symptoms, and quality-of-life scores at 52 weeks.

Meanwhile, the ANCHOR-1 and ANCHOR-2 trials in CRSwNP showed that the drug was able to nasal polyp size, as well as nasal obstruction compared to placebo over a year.

GSK is also running trials of the long-acting antibody in EGPA (OCEAN) and HES (DESTINY), and has suggested it may also run trials in COPD, depending on the outcome of its Nucala filing in that indication, which is based on the MATINEE trial data. In that study, Nucala was shown to reduce exacerbations across the full spectrum of COPD patients.

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