AstraZeneca FDA vote worth potentially US$500mln annual peak sales
AstraZeneca PLC forecasts for its major Lynparza drug are expected to be trimmed following an advisory vote against full approval in the US.
In a US Food & Drug Administration advisory committee meeting to discuss Lynparza’s regulatory filling for first-line metastatic castrate-resistant prostate cancer (mCRPC), based on Phase III data, the committee voted 11-1 against approving the drug in an all-comer population.
This suggests, said analyst Sean Conroy at Shore Capita, the US regulator may now look to only approve use in men harbouring BRCA mutations (BRCAm), which he understands is only around 10% of front-line patients.
A final decision from the regulator was predicted by Conroy to come through before the end of the first half.
"Whilst these votes are non-binding, they are typically upheld by FDA," he said, adding that the outcome is disappointing as it follows European approval in December with a broad label covering all patients, irrespective of BRCA or HRR status, "and we understand initial uptake has been strong".
The analyst noted that AstraZeneca has previously described the PROpel indication as a blockbuster opportunity.
"We’d expect long-term forecasts for the drug to edge down as a result of this vote," he added, noting the consensus forecast is circa US$5bn sales in 2027F, of which circa US$1.5bn relates to its use in prostate cancer.
Assuming roughly half of these relate to the US, Conroy estimated peak forecasts would edge down by circa US$500mln.
The remainder of sales he expects would be supported by the drugs approved use in a second-line setting and the potentially limited front-line setting based on PROpel data.
"In the grand picture of AstraZeneca mind, we would view this move as relatively minor given this would represent less than 1% of our overall FY27F sales," the analyst said.
"We don’t see ex-US forecasts at risk given the broad label in European. It is worth noting however that a regulatory milestone from Lynparza is broadly expected to be received from Merck in relation to this approval and it is unclear how this may be impacted; a c.$105m milestone was received on the PROpel approval in European."
Tue 02 May 2023