Astrazeneca asthma drug to be fast-tracked
ASTRAZENECA has won “breakthrough therapy” status on one of its experimental treatments for severe asthma meaning it will be fast-tracked through the approvals process, saving vital time and money for the pharmaceuticals company.
The drug, called tezepelumab, showed such promising results in mid-stage clinical trials that the US Food and Drug Administration (FDA), which approves medications, granted it fast-track status.
Tezepelumab’s development will be expedited and the FDA will give it priority through the approvals process.
Clinical trials suggest tezepelumab reduced asthma attacks by as much as 71pc in people who suffer from a severe form of the illness. If approved the drug, which is injected into the body, would be the first medication of its kind on the market.
Belonging to a class of drugs called monoclonal antibodies, it is part of a new wave of respiratory drugs called “biologicals” which treat the underlying causes of disease, rather than the symptoms.
It works by binding to and blocking a specific protein that causes inflammation in the airways. It could help a wide range of patients with severe asthma.
Tezepelumab is being developed by Astrazeneca in collaboration with US biopharma company Amgen.
Breakthrough status from the FDA is a coup for Astrazeneca. It will help the company bring the drug to market faster, potentially beating rivals who have similar products in their pipeline. Astrazeneca, Glaxosmithkline, Sanofi and Teva Pharmaceuticals already have biological asthma medications on the market, but these appear to help only patients with a certain type of asthma. Tezepelumab, which works further “upstream” in the body, could benefit a much wider range of people.
Sean Bohen, chief medical officer at Astrazeneca, said: “Tezepelumab is exciting because it has the potential to treat a broad population of severe asthma patients, including those ineligible for currently approved biologic therapies.”
Respiratory is one of five key therapeutic areas in which Astrazeneca is developing drugs.
Shares in Astrazeneca closed up 15p at £56.50.