The FDA brushes off the pandemic with a pick-up in novel drug approvals

The US drugs regulator approved 58 novel drugs last year, the highest number for three years and well above the 10-year average of 48. With travel limitations blamed for decision delays in a number of cases, Novartis’s Leqvio and UCB’s Bimzelx included, this uptick could presumably have been steeper under more normal conditions. The only Covid product included in this count is Biontech and Pfizer’s Comirnaty; all the other pandemic-related projects are on the market under emergency use authorisations, rather than full approvals. The mRNA vaccine is almost certainly going to become last year’s biggest approval commercially speaking, though by 2026 sales are forecast to have dipped substantially. This time last year Biogen’s Aduhelm was looking like the class of 2021's biggest seller, according to fifth-year sales as predicted by sellside analysts. Should last week’s punitive US coverage decision hold consensus is likely to drop to close to zero. That still leaves plenty of potential future blockbusters that arrived on the market last year, according to Evaluate Pharma's consensus in the table below. That said, it is worth remembering that several of these projects need to win expanded labels, or carve out share in highly competitive therapy areas, to reach these lofty levels.

Predicting great things: 2021's arrivals with blockbuster potential
Product Company Description  2026e US sales 
Leqvio Novartis siRNA-based anti-PCSK9 for high cholesterol; approved in heterozygous familial hypercholesterolaemia and atherosclerotic cardiovascular disease.  $1.7bn
Abecma Bristol Myers Squibb/Bluebird Anti-BCMA Car-T cell therapy; approved for B-cell and follicular lymphomas  $1.4bn
Comirnaty Pfizer Covid-19 vaccine  $1.4bn
Tezspire Amgen Anti-TSLP MAb; approved in severe asthma $1.2bn
Vyvgart Argenx Anti-FcRn MAb for IgG-mediated autoimmune diseases; approved in myasthenia gravis $1.2bn
Lumakras Amgen Kras G12C inhibitor; approved in non-small cell lung cancer $1.2bn
Lupkynis Aurinia  Calcineurin inhibitor; approved in lupus nephritis $1.1bn
Source: Evaluate Pharma.

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