A year of two halves for US approvals

FDA green lights picked up in the second half, but for the really impressive number look at year-five sales.

A slow start to US approvals translated into an only slightly disappointing 2022, as the pace of FDA green lights picked up in the second half and the year ended with 42 new drugs registered.

True, this was down on the 10-year average of 48, and on the remarkable 58 drugs the FDA had approved, despite the Covid pandemic, in 2021. But delays pushed decisions on at least six new projects into 2023. And on at least one metric last year did not disappoint: combined US sales of drug approved in 2022 are set to hit nearly $27bn within five years.

If accurate this forecast, based on Evaluate Pharma sellside consensus, would actually make 2022 the most successful year for US approvals since 2019. This is largely down to Lilly’s diabetes drug Mounjaro, which is expected to bring $6.8bn in 2027 US revenues, a consensus that will likely go up as analysts update their forecasts with an anticipated label expansion into obesity.

The approval of Mounjaro in May crowned a first half in which just 19 news drugs were greenlit. The second half brought 23 more, including approvals for Mirati’s Kras inhibitor Krazati, Bristol Myers Squibb’s Tyk2 inhibitor Sotyktu and Gilead’s long-acting HIV drug Sunlenca.

The year’s total could have been higher still were it not for delays. Covid-related restrictions meant that agency officials could not travel to China to inspect facilities, meaning that approval action dates were missed for three anti-PD-1 MAbs: Beigene/Novartis’s tislelizumab, Akeso/Sino’s penpulimab and Coherus’s toripalimab (at the second time of asking).

Meanwhile, Apellis’s intravitreal pegcetacoplan, potentially the second-biggest 2027 seller, was one of three assets handed three-month Pdufa date extensions that pushed decisions into 2023. The other two were Travere’s sparsentan, over an updated proposed risk-evaluation and mitigation strategy, and Biogen’s tofersen, owing to new information constituting a major amendment.

2022's arrivals with blockbuster potential
Product Company Description 2027e US sales ($bn) 
Mounjaro Lilly Type 2 diabetes 6.8
Vabysmo Roche AMD & diabetic macular oedema 1.8
Opdualag Bristol Myers Squibb Lag3 + PD-1 combo for melanoma 1.4
Carvykti Johnson & Johnson Car-T for 5th-line multiple myeloma 1.2
Vtama Roivant Sciences Non-steroidal topical for plaque psoriasis 1.1
Pluvicto Novartis Radioligand therapy for PSMA+ve prostate cancer 1.1
Sotyktu Bristol Myers Squibb Moderate-to-severe plaque psoriasis 1.1
Sunlenca Gilead Sciences Resistant HIV (resubmission) 1.1
Camzyos Bristol Myers Squibb Cardiomyopathy  1.0
Spikevax Moderna Covid-19 vaccine 1.0
Source: Evaluate Pharma.

Among other potential blockbusters approved last year Bristol Myers Squibb’s Opdualag features as including a notable new immuno-oncology mechanism, Lag3 inhibition, while J&J’s Carvykti became the second BCMA-targeted Car-T therapy after Bristol’s Abecma.

Moderna’s Spikevax features despite having been sold since 2020, by virtue of its emergency use authorisation being converted to a formal approval; 2021’s totals benefited from Pfizer/Biontech’s Comirnaty being treated in a similar way.

What can investors nervously eyeing the start of 2023 expect in the current year? On the plus side Eisai/Biogen’s Leqembi has made it across the line in remarkably low-key fashion, and several other US decisions are due. However, the FDA has started a severe clampdown on accelerated approvals, so the days of regulatory largesse are probably over.

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