US regulator brings year-end joy for some

While Astrazeneca celebrated US approval on Friday for Tagrisso in an adjuvant lung cancer setting, it had less luck with its Fibrogen-derived HIF-PH inhibitor roxadustat. The FDA has delayed its decision over roxadustat in anaemia of chronic kidney disease by three months to March 20, pending further clinical data analyses; still, as long as this is the only outstanding issue it probably bodes well for eventual approval. Novartis’s cholesterol-lowering RNAi project Leqvio was also knocked back on Friday, with its complete response letter continuing a growing trend seen during the coronavirus pandemic. The group had earlier said that a paper-based inspection of a manufacturing plant in Italy was outstanding, and now cites “unresolved facility inspection-related conditions” as the reason for the CRL. If a physical inspection is required this will clearly be impossible until Covid-19 travel restrictions are eased, possibly causing further delay. For investors the highest-profile Covid-19-related delay remains that over Bristol Myers Squibb’s liso-cel, whose Texas manufacturing plant could not be inspected during the pandemic, resulting in the FDA missing its November 16 action date. Curiously, neither a CRL nor a new action date has been issued.