Pharmaceuticals giant astra-Zeneca saw shares tumble after approval for a new heart drug was delayed by a us regulator's demand for more information.the Food and Drug administration (FDa) wants further analysis of research into Brilinta a bloodthinning pill before it clears the drug for sale in the us.
The move could set astra-Zeneca's us plans back by nine months. shares fell more than 6 per cent yesterday.the group, which employs 11,000 staff in the uK, won marketing approval in europe earlier this month for
Brilinta and a similar vote was expected from the FDa, but the regulator now wants more details from a recent study on the drug.
Astra has shifted focus on to new drugs like Brilinta in the wake of increased competition from cheaper rivals.
Brilinta, like the market's leading anti-clotting drug Plavix, is designed to keep blood platelets from sticking together in order to prevent blood clots that can lead to heart attacks and strokes.
The company recently conducted the study into Brilinta on nearly 20,000 patients who had been treated for a heart attack or worsening chest pain in 43 countries.
Astra's submission was based on the results of this trial.
Astra said it remained confident the FDa will not require additional clinical trials – which would be costly for the company – and plans to provide the additional analysis as soon as possible.
AstraZeneca recently posted a 26 per cent drop in pre-tax profits in its third quarter to $2.2bn (1.4bn).