The big approvals still on the cards for 2021

Biogen’s Aduhelm was the big one, but there are plenty of other key regulatory decisions still pending this year.

NME approvals

Biogen got a win last week with US approval of its Alzheimer’s drug Aduhelm, but there are plenty of other developers still waiting for regulatory decisions. In fact, a look back at Evaluate Vantage’s preview of the year’s 10 potential biggest launches, written in January, shows that, almost half way through 2021, only three have received a green light.

As well as Aduhelm, this includes Bristol Myers Squibb’s Car-T therapies Abecma and Breyanzi, verdicts on which came too late for holders of the Celgene CVR. Ascendis had been hoping to join that club next week but instead had the review of its growth hormone project extended by three months. That leaves Axsome's AXS-05 and Chemocentryx's avacopan as the next big projects up for an approval decision.

January's analysis looked for the 10 biggest potential launches this year as predicted by sellside consensus, collated by Evaluate Pharma. Projects being developed for Covid-19 were excluded. The table below reviews the progress of the assets in that original article that are still awaiting regulatory verdicts. 

Waiting in the wings: the big regulatory decisions still pending for 2021
Project  Setting  Company Status 2026e sales ($bn) 
Efgartigimod Anti-FcRn MAb for IgG-mediated autoimmune diseases Argenx Dec 17 Pdufa date for myasthenia gravis 2.9
Leqvio (inclisiran) siRNA-based anti-PCSK9 for high cholesterol Novartis CRL; company guided to response in Q2-Q3 2.1
Evrenzo (roxadustat) HIF-PH inhibitor for anaemia Astrazeneca/ Astellas/ Fibrogen Delayed for adcom, scheduled for Jul 15; EMA decision due mid-year 2021 2.6*
Bimekizumab Anti IL-17A&F MAb for psoriasis UCB Oct 15 Pdufa date for psoriasis; EMA decision due Q3 2021 2.6
TransCon Growth Hormone Long-acting human growth hormone Ascendis Pharma Pdufa date pushed back by 3 months to Sep 25; EMA decision due Q4 2021 1.5
AXS-05 NMDA receptor antagonist Axsome Therapeutics Aug 22 Pdufa date for major depressive disorder 1.3
Vynpenta (avacopan) Complement factor C5a inhibitor Chemocentryx July 7 Pdufa for vasculitis; EMA decision due H2 2021 0.7**
*Combined partner sales. **Fallen from $1.1bn in Jan. Source: Evaluate Pharma.

Sales forecasts are constantly shifting, of course, so the table above represents a snapshot in time. Other projects have been green lit this year that are now considered to be as potentially valuable as those listed above, such as Amgen's Kras inhibitor Lumakras and Aurinia's Lupkynis. 

The table below sets out the biggest approvals of the year so far, with Aduhelm at the top of the list. The $1.9bn figure is a pre-approval consensus, which had been substantially reined in in the wake of a negative advisory committee hearing. The number will soon be heading very far north with last week’s surprise FDA verdict. Although a slow launch is expected, and real concerns remain around the therapy’s true effectiveness, most believe that Aduhelm is on track to become a mega-blockbuster.

As such, the Biogen MAb could well turn out to be 2021’s biggest launch. But others are looking like potentially large projects, should they pass muster. Argenx’s efgartigimod, for example, is some way off a decision, but expectations are sky high for the project and the FcRn class more broadly.

However, others now look unlikely to reach the market this year. Novartis has yet to confirm that it has responded to the FDA’s complete response letter for Leqvio, making a 2021 decision highly unlikely. And it remains to be seen what regulators will make of Fibrogen’s roxadustat; the company recently admitted presenting the wrong data, raising further doubts about the safety of the novel anaemia project.

It is also worth pointing out that Novo Nordisk's new obesity drug Wegovy, a once-weekly formulation of semaglutide, which is already sold for type 2 diabetes, carries a sales forecast of $2.4bn by 2026. While first-time approvals of novel products garner much attention, the huge potential that lies in brand extension should not be forgotten. 

The potential blockbusters approved in 2021... so far
Drug Description Company 2026e sales ($bn)
Aduhelm Anti-beta amyloid MAb for Alzheimer's disease Biogen/Eisai 1.90
Lumakras Kras G12C inhibitor for lung cancer Amgen 1.76
Breyanzi Anti-CD-19 Car-T therapy for lymphoma Bristol Myers Squibb 1.27
Abecma Anti-BCMA Car-T therapy for myeloma Bristol Myers/Bluebird 1.20
Lupkynis Calcineurin inhibitor for lupus nephritis Aurinia 1.08
Prevnar 20 Pneumococcal vaccine Pfizer 1.04
Zynlonta Anti-CD19 ADC for late-stage large B-cell lymphoma ADC Therapeutics 1.03
Cabenuva Once-monthly long-acting HIV therapy Glaxosmithkline 0.91
Source: Evaluate Pharma. 

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