Pharmaceutical company AstraZeneca (AZN) said that the advisory committee to the US food and drug administration had not recommended the company’s chronic kidney disease drug roxadustat for approval, knocking 0.5% off the shares to £83.10.
Pharmaceutical guru Dr. Adam Barker at Shore Capital commented: ‘Although the recommendation of the advisory committee is not binding, the FDA will consider this recommendation and it is not uncommon to see the regulator follow the advice of advisory committees.
‘As such, we would not expect roxadustat to be approved in the US at this stage based on existing data.’
This follows AstraZeneca’s partner FibroGen’s update in April which said the safety profile had been less compelling on updated data.
Roxadustat is approved in several countries, including China, Japan, Chile and South Korea, for the treatment of anaemia in chronic kidney patients who are non-dialysis dependent and dialysis dependent. It is under regulatory review in others including the EU.
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Dr. Barker said that while he expected consensus estimates for risk-adjusted peak revenues to be downgraded following today’s announcement, he would leave his estimates unchanged because he hadn’t included much benefit from the drug due to his earlier concerns.
Prior to the update from FibroGen, consensus estimates had been for the drug to generate between $1billion and $2 billion in risk adjusted peak revenues, according to Dr. Barker.
