In a year featuring high-profile rejections and Covid-19-related inspection delays, the number of new drug approvals might have been expected to decline. Not so. Despite everything that happened in 2020, there were actually more US green lights last year than in 2019.
Over the course of 2020 the agency approved 57 novel medicines with a fifth-year sales potential of $21.6bn, according to an Evaluate Vantage analysis of EvaluatePharma data – numbers that hold up well against the pre-pandemic years.
The FDA also granted these approvals faster than it did in 2019: last year’s mean time to approval was 11.2 months, compared with 12.3 months the previous year. This was largely down to the 23 projects in 2020 that were assessed under priority review, and made it to market in an average of 7.3 months – speedier than every year in recent memory apart from 2006.
Still, only one of the class of 2020 made it into the 10 fastest approval decisions since 2010: Gilead’s Covid-19 therapy Veklury, which received full approval in October, 2.5 months after being filed. The antiviral drug had already received emergency use authorisation in May.
This analysis does not include EUAs – although, in contrast to the diagnostics world, there were only a handful of these in biopharma, including authorisations for Regeneron and Lilly’s rival Covid-19 antibodies, and Covid-19 vaccines from Pfizer/Biontech and Moderna.
Excluding these only seven drugs were approved in less than six months last year, compared with 11 in 2019 – perhaps a sign that the FDA is showing the strain from the pandemic.
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This strain led to the saga of whether Bristol Myers Squibb’s liso-cel would get the go-ahead by December 31, the deadline for a contingent value right related to Bristol’s takeover of Celgene. Covid-19 travel restrictions prevented the FDA from inspecting a manufacturing plant in time, and there is still no word on when a decision on liso-cel might be expected.
Novartis suffered a similar fate with Leqvio (inclisiran), and it emerged yesterday that Glaxosmithkline’s anti-PD-1 project dostarlimab has also been also hit by a Covid-related inspection delay.
If the pandemic carries on causing travel disruption, this might be a trend that continues into 2021.
Last year’s approval tally is all the more impressive when these issues are taken into account. But the crop of drugs is less exciting than in previous years, at least based on current sales expectations from the sellside.
The chart below looks at the total commercial potential of last year’s NMEs given the greenlight by both CDER and CBER divisions; the $21.6bn figure includes just six drugs expected to become blockbusters, and only one – Horizon’s thyroid eye disease therapy Tepezza – that is forecast to bring in over $2bn in the US by 2025.
One big product not included in this analysis is Novartis’s Kesimpta. The drug's go ahead in relapsing multiple sclerosis in August was a supplemental approval; it was already marketed for chronic lympocytic leukaemia, as Arzerra. Still, its 2025 forecast sales of $2.6bn are all expected to come in MS.
The fifth-year sales number will also not have been helped by the fact that some big-ticket projects missed out on approval last year: the aforementioned Leqvio and liso-cel are both expected to become blockbusters, as is Astrazeneca and Fibrogen’s roxadustat, which was hit by a three-month delay at the tail end of 2020.
But things could have been worse. After the high-profile rejections of Gilead/Galapagos’s Jak inhibitor filgotinib and Biomarin’s haemophilia A gene therapy valrox in the summer, there had been fears among industry watchers that the FDA was finally baring its teeth. This latest analysis suggests that the agency is as friendly to biopharma as ever.