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.

Friday's US FDA decisions
Product Company Indication Action
Tagrisso Astrazeneca Adjuvant EGFR exon 19 del, or exon 21 L858R mut, NSCLC (Adaura study) Approved
Roxadustat Astrazeneca/Fibrogen Anaemia of chronic kidney disease 3-mth delay to 20 Mar 2021 over clinical data analysis issues
Leqvio Novartis/Alnylam Hyperlipidaemia with elevated LDL cholesterol CRL over manufacturing facility inspection-related issues
Xpovio Karyopharm 2nd-line multiple myeloma (Boston study) Approved 3 mths early (already had accelerated approval in penta-refractory use)
Orgovyx (relugolix) Myovant/Sumitomo Hormone-sensitive prostate cancer (Hero study) Approved
mRNA-1273 Moderna Prevention of Covid-19 Emergency use authorisation (1 day after positive adcom vote)

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