EU approval for new asthma drug Exdensur lifts GSK

GSK has claimed approval in the EU for Exdensur, a long-acting respiratory drug that is considered one of its top growth prospects.

The approval of Exdensur (depemokimab) for severe asthma and chronic rhinosinusitis with nasal polyps by the European Commission comes a few weeks after it was cleared in the UK and Japan for the same indications, and for severe asthma only in the US.

It adds another 3 million potential patients for the drug, according to GSK, which is also waiting for a regulatory decision in China this year.

Exdensur is in the same IL-5 inhibitor class as GSK's established severe asthma therapy Nucala (mepolizumab), which generated more than £2 billion ($2.7 billion) in sales last year, but can be injected just twice a year, while Nucala needs to be dosed every month.

The company has said it believes Exdensur could make peak annual sales of £3 billion if approved across all its proposed indications, which also include eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic obstructive pulmonary disease (COPD).

Specifically, Exdensur has been cleared in the EU as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype and whose symptoms can't be controlled with high doses of corticosteroids plus another asthma drug.

In CRSwNP, the label covers its use as an add-on to intranasal corticosteroids for adults with the condition for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.

Kaivan Khavandi, head of respiratory, immunology, and inflammation R&D at GSK, said that Exdensur has the potential to "redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year."

Shares in GSK had risen around 2% this morning following the announcement, push the stock close to its 52-week high.

Exdensur is one of the new products highlighted by GSK's new chief executive, Luke Miels, as being key to its near-term growth, at its fourth-quarter results update earlier this month.

Others include multiple myeloma therapy Blenrep (belantamab mafodotin), which was recently returned to the market, paediatric vaccine Penmenvy, and novel antibiotic Blujepa (gepotidacin). It is also hoping for a big contribution from Nucala's recent approval as a treatment for chronic obstructive pulmonary disease (COPD).