US FDA approval tracker: December 2020

While 2020 ended with two Covid-19 vaccines receiving emergency use authorisations from the FDA, the year also saw regulatory knockbacks and delays owing to the pandemic, a trend that will likely continue into 2021. Novartis’s cholesterol-lowering project Leqvio received a thumbs down because of a manufacturing inspection delay, an issue that also scuppered Bristol Myers Squibb’s liso-cel, whose delay led to the missing of an important December 31 CVR deadline. Elsewhere the final decision for Astrazeneca and Fibrogen’s anaemia pill Evrenzo was delayed until March pending further clinical data analyses. Lipocine, meanwhile, only received a tentative approval for its oral testosterone-replacement therapy Tlando. Lipocine is also currently embroiled in a legal wrangle with Clarus Therapeutics over intellectual property; Clarus’s own oral drug Jatenzo got its FDA nod in 2019 and the group is unlikely to want new competition.