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The first twice-yearly biological medicine for use as an add-on treatment for asthma in adults and adolescents aged 12 years and older, and as an add-on treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP ) in adults, has been approved by the MHRA.

GSK has been granted marketing authorisation for depemokimab (brand name Exdensur) for patients whose symptoms remain inadequately controlled despite standard treatment, including surgery in the case of CRSwNP.

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has also recommended the approval of depemokimab for these two indications with a decision expected early next year.

The positive opinion is based on data from the SWIFT and ANCHOR phase III trials which showed sustained efficacy with a twice-yearly dosing regimen. Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, says GSK.

Asthma affects more than 42 million people in Europe. About 5-10 per cent of patients experience severe asthma, and many continue to experience exacerbations and reduced quality of life despite treatment. Depemokimab’s sustained suppression of type 2 inflammation has the potential to address the underlying drivers of additional diseases such as CRSwNP, helping to alleviate associated symptoms.

The pooled results from SWIFT showed a 54 per cent reduction in clinically significant exacerbations (asthma attacks) over 52 weeks. Additionally, this pooled analysis showed a 72 per cent reduction in the secondary endpoint of clinically significant exacerbations requiring hospitalisation or emergency department visit compared to placebo.

Pooled results from the ANCHOR trials showed an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks and in nasal obstruction over weeks 49-52

Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.