An injection taken just twice a year that could prevent thousands of asthma patients from life-threatening attacks is expected to be launched in Britain within months.
Clinical trials show that the new "ultra-long-acting" drug, called depemokimab, reduces hospitalizations by 72 percent, while causing very few side effects.
This injectable therapy, part of a group of drugs known as biologics, contains antibodies that reduce inflammation in the lungs and is expected to radically change the treatment of severe asthma.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for the treatment, which is manufactured by British pharmaceutical giant GSK. The drug is expected to be available on the private market in the first half of 2026, while NICE will decide whether it will be included in the public health system (NHS).
"Like a laser-guided missile"
Professor Ian Pavord, an expert in respiratory medicine at the University of Oxford and the director of the clinical trial for depemokimab, compared biological therapies to a “laser-guided missile.”
“They directly hit the 'enemy', whereas non-specific anti-inflammatory drugs — especially steroids — are like cluster bombs,” he said.
"Steroids have a lot of side effects that we don't want. With biologics, about a third of patients achieve complete remission of asthma, moving out of a state of extreme despair."
Biologics are considered lifesavers for patients with severe, uncontrolled asthma for whom inhalers are not enough. Previously, these patients were treated with high doses of steroids, which are associated with serious side effects such as mood swings, weight gain, high blood sugar and osteoporosis.
Depemokimab, which will be marketed under the name Exdensur, has the great advantage of being taken only once every six months, unlike current biologics for asthma, which require injections every two to eight weeks.
GSK Chief Executive Dame Emma Walmsley said:
“It's terrifying for a patient — or a parent — to end up in the hospital due to an asthma attack.
We now have the world's first approved treatment for asthma that is taken every six months.
"Our studies show that this drug significantly reduces seizures that lead to hospitalization — the most frightening ones."
Who can benefit?
Around 6 million people in England suffer from asthma. Of these, an estimated 58 adults have severe, uncontrolled asthma that would make them suitable for biologic treatment. However, only around 21 are currently taking these drugs, according to a recent study by the University of Cambridge.
Professor Pavord called the development of biologics a "British success story", noting that a large part of the clinical development has been done in the UK.
For his part, Kaivan Khavandi, head of respiratory disease research at GSK, said the six-month dose would help patients who are afraid of needles, reduce absences from work for medical appointments and free up NHS resources.
Extending the intervals between doses usually requires increasing the dose, which often carries the risk of toxicity and side effects. GSK scientists in Stevenage managed to avoid this by making two structural changes to the antibody, making the drug effective for six months without increasing the risks.
Price, access key
Professor Nick Hopkinson, medical director of the charity Asthma + Lung UK, called the development:
"An important step forward. Biological therapies are becoming increasingly common and this allows patients to live normally without frequent treatments."
Meanwhile, Professor David Jackson from King's College London warned that the number of patients who will benefit from depemokimab will depend heavily on the price that GSK sets, which is expected to be made public in the coming weeks.
This is because NICE currently sets the criteria for most biologics at least three severe crises per year to qualify for treatment on the NHS.
"Our hope as a medical community is that the price will be low enough so that this threshold is lowered, for example to two exacerbations per year, and more patients benefit," he concluded.
If expectations are realized, depemokimab could mark a new era in the treatment of severe asthma — fewer attacks, fewer hospitalizations and a much more normal life for thousands of patients. /GazetaExpress/
t7 live
