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AstraZeneca’s drug for severe asthma approved in UK, EU and Japan




An AstraZeneca drug to treat severe asthma has been authorised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

It follows days after Tezspire (tezepelumab) was also approved in the EU, where it became the first biologic for patients with severe asthma and no phenotype or biomarker limitations.

It has been authorised in the UK and EU as an add-on maintenance treatment in patients 12 years and older with severe asthma, whose condition is inadequately controlled with high dose inhaled corticosteroids and another medicinal product.

AstraZeneca’s Discovery Centre on Cambridge Biomedical Campus
AstraZeneca’s Discovery Centre on Cambridge Biomedical Campus

Ed Piper, medical and scientific affairs director, AstraZeneca UK, said: “We are thrilled that the MHRA has authorised tezepelumab, a first-in-class biologic therapy that targets the top of the inflammatory cascade. Today’s milestone supports AstraZeneca’s overall ambition to reduce the risk of respiratory attacks in the UK through the use of effective, biologic treatments. We are working with NICE, the SMC and NHS England to ensure eligible patients have access to tezepelumab as quickly as possible.”

Japan followed suit by authorising the drug this week.

[Read more: AstraZeneca to fund 55 more PhD studentships at University of Cambridge over five years]

It comes amid a raft of drug approvals for AstraZeneca.

Japan also approved Koselugo (selumetinib) for the treatment of paediatric patients aged three and older with plexiform neurofibromas (PNs) in neurofibromatosis type 1 (NF1) facing clinical symptoms such as pain and disfigurement, and for PNs which cannot be completely removed by surgery without risk of substantial morbidity.

Ultomiris (ravulizumab) has been approved in Europe as an add-on to standard therapy for the treatment of some adult patients with generalised myasthenia gravis (gMG). And AstraZeneca and MSD’s Lynparza (olaparib) has been approved in China for the maintenance treatment of some adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.



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