GSK closes on approval of asthma hope depemokimab

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GSK closes on approval of asthma hope depemokimab

Among seven new medicines recommended for approval by the EMA's human medicine advisory committee at its latest meeting is GSK's depemokimab, a long-acting anti-IL-5 antibody for severe asthma and an inflammatory condition that causes nasal polyps.

GSK hopes that depemokimab – which has the proposed trade name of Exdensur in the EU – will become the first drug for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) that can be given as a subcutaneous injection just twice a year. It is formulated either as a pre-filled pen or syringe.

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. The positive opinion by the CHMP comes just ahead of the deadline for a decision on the marketing application for depemokimab in the US, which comes tomorrow.

The recommendation is for the drug's use 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 high doses of corticosteroids plus another asthma drug.

Its label also covers the use of the antibody as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control.

Kaivan Khavandi, head of respiratory, immunology, and inflammation R&D at GSK, said depemokimab "could help redefine care for millions of patients" with severe asthma and CRSwNP in the EU.

The CHMP delivered another major win for GSK's respiratory diseases business, meanwhile, by backing the use of its current, once-monthly IL-5 inhibitor – Nucala (mepolizumab) – for the additional indication of chronic obstructive pulmonary disease (COPD).

Nucala is already approved for severe eosinophilic asthma, CRSwNP, and rare diseases eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome, but use in COPD – which affects more than 300 million people globally – could lend further momentum to a product that generated £1.44 billion ($1.92 billion) in sales for GSK in the first nine months of this year.

Nucala was approved for use in adult patients with inadequately controlled COPD and an eosinophilic phenotype in the US, its first market, earlier this year.

Other CHMP decisions

The CHMP's December meeting also included the following positive opinions:

  • Serum Life Science Europe's IL-15 receptor agonist Anktiva (nogapendekin alfa inbakicept) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours;
  • SFL Pharma's EGFR tyrosine kinase inhibitor Aumseqa (aumolertinib), for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC);
  • Cytokinetics' Myqorzo (aficamten) for the treatment of adults with obstructive hypertrophic cardiomyopathy (HCM); and
  • Moderna's Mnexspike vaccine for the prevention of COVID-19 in people from 12 years of age.