Top 10 most anticipated drug launches of 2022

Top 10 most anticipated drug launches of 2022

buy Adderall 30mg Without Prescription Overnight Shipping.By Ben Adams

Feb 7, 2022 12:00am

Alzheimer’sDiabetesdrug launchOncology

Sleeping pills

Tapping Evaluate Vantage’s figures, Fierce Pharma Marketing ranks and reviews the field of wannabe blockbuster drugs for 2022. (Getty Images)

After 55 new drug approvals at the FDA last year,

biopharma and the U.S. agency are still going all guns blazing in getting new therapies out to patients.

But what are the most hotly tipped—and potentially most lucrative—approvals on the horizon for 2022?

Well, there’s a real eclectic mix of targets here, from Alzheimer’s disease and diabetes to psoriasis and lung cancer. And, according to the life sciences data crunchers

at Evaluate Vantage, the top 10 most anticipated drugs are set to make a collective $26.9 billion by the middle of the decade.

It’s Eli Lilly’s year in 2022,

with the top two biggest prospects

belonging to the Big Pharma and taking nearly half that total with just shy of $11 billion in potential earnings from its prospective drugs in Alzheimer’s and diabetes, respectively.

Overall, it’s the Alzheimer’s drug prospects that dominate the sales

charts as a group, with Lilly’s donanemab worth potentially $6 billion by 2026 and Roche’s rival gantenerumab set to take $2.5 billion.

That’s $8.5 billion in total potential in a disease area that hadn’t produced a new therapy for nearly two decades. But with Biogen’s ongoing woes with Aduhelm—which

also had sky-high expectations last year but has faced what could be the worst launch in drug history—the Lilly and Roche predictions may be some of the riskiest we’ve seen in many years.

It’s also a good launch year for Bristol Myers Squibb,

which, like Lilly, has two drugs in the top 10. Its hopefuls mavacamten

in cardiomyopathy and deucravacitinib in psoriasis and autoimmune disorders are together worth $4 billion in predicted peak sales.

But it’s not been an easy path to 2022 for all of the top 10: Johnson &

Johnson and Legend Biotech were hit by an extended FDA review that pushed an expected decision from November to late February over manufacturing and technical concerns. And mavacamten had its own FDA delay to contend with.

And, while Alzheimer’s drugs may be the riskiest proposition launch-wise,

Reata Pharmaceuticals is at the highest risk of falling short of an approval.

An FDA advisory committee unanimously rejected its kidney disease

hopeful bardoxolone last year, putting its projected $2.2 billion in 2026 sales in serious jeopardy.

Check out the top 10 most anticipated drug launches of the year below. You can find last year’s edition here. As always, let us know your thoughts on these or any upcoming meds you think we missed.

1. Donanemab

Drug: Donanemab
Company: Eli Lilly
Used for: Alzheimer’s disease
Est. 2026 sales: $6 billion

It’s a case of déjà vu for the most hotly anticipated drug launches of the year as,

once again, it’s an Alzheimer’s disease drug that leads Evaluate Vantage’s highest-grossing potential list. Last year, that honor went to Biogen’s amyloid therapy aducanumab, which was approved in June as Aduhelm.

Evaluate had forecast peak sales for that drug at around $4.8 billion in 2026.

This year, it’s Eli Lilly’s turn to take the top spot, with Evaluate eyeing a beefier $6 billion in sales for its Alzheimer’s hopeful donanemab. Like Aduhelm, donanemab is also an anti-amyloid beta monoclonal antibody, but Lilly hopes to best its rival and thus gain greater market share.

These are big figures, but there’s also plenty of room for doubt that the

drugs using this approach to fight Alzheimer’s—and that includes No. 3 on our list, another Alzheimer’s hopeful from Roche—can actually measure up to these estimates. Biogen, in fact, only made $300,000 from Aduhelm in the third quarter of 2021.

And there’s a reason for that:

An FDA advisory panel originally rejected the drug, which has questionable

efficacy and fresh safety concerns, but the agency granted an accelerated approval based on biomarker evidence.

RELATED: Biogen hits the gas pedal on Aduhelm confirmatory trial, hoping to deliver results in 2026

Biogen also priced the drug very high, at $56,000, before slashing

the sticker price in half at the end of last year. It’s had possibly one

of the worst drug launches in history, with a number of physicians and medical groups questioning its worth and refusing to prescribe it.

As Biogen’s biomarker evidence showed, the drug can clear sticky proteins, known as amyloid, that can clog the brain. It is believed that amyloid plaques could be an

underlying cause of Alzheimer’s, though this has not been directly proven, and the theory has seen many drugs fail in the past. It also remains an open question as to whether clearing it can actually help reduce Alzheimer’s symptoms.

But the FDA, in approving Aduhelm,

set a precedent that clearing

amyloid is an acceptable bar for getting an Alzheimer’s drug on the market.

Hence, after nearly two decades of no new drugs for the disease, Roche, Lilly and other

drugmakers have suddenly jumped back into action.

Lilly is not going in with blind optimism. Mindful of Biogen’s woes, the Big Pharma decided last year to run a head-to-head clinical trial for donanemab against Aduhelm.

Analysts from Evercore ISI see donanemab as reducing amyloid more

than other similar drugs—including Aduhelm—which could give it a market edge.

RELATED: Eli Lilly kick-starts speedy FDA review for Alzheimer’s hopeful donanemab—and a one-on-one test against Aduhelm

In comparing the data on Lilly’s drug to Aduhelm’s,

the Evercore ISI team saw an advantage for donanemab—and figured

those data gave Lilly confidence to run the head-to-head test.

Comparing different trials is always full of caveats, but, if Lilly can prove this thesis, it will be a major win for the pharma.

In preparation for donanemab’s potential launch, Lilly is already

working to build out its commercial capabilities in neuroscience, Lilly’s Chief Commercial Officer Anat Ashkenazi told Fierce Pharma recently. With the donanemab launch in mind, the company split its Bio-Medicines business into two units last July, one focused specifically on neuroscience.

Lilly has submitted the drug for an accelerated approval and expects

to complete its rolling submission by the end of the first quarter. If all goes to plan at the FDA, the company aims to launch donanemab toward the end of the year.

RELATED: The top 10 most anticipated drug launches of 2021

Donanemab is also slated to have results from a confirmatory trial

by 2023, three years ahead of Biogen,

which isn’t expecting data from its confirmatory trial until 2026.

Lilly says it expects limited sales when the drug first hits the scene,

but the arrival of phase 3 data in 2023 could serve as another “inflection point” for the drug, Ashkenazi said. By the middle of next year, Lilly expects to have data from that head-to-head trial against Aduhelm as well.

Should donanemab gain the green light, Lilly will, however, likely still

come up against some of the same issues that have been plaguing Biogen.

It may gain approval, but in the real world, it will still need to be priced competitively and show

it can actually help patients if it wants to hit that $6 billion sales figure.

2. Tirzepatide

Drug: Tirzepatide
Company: Eli Lilly
Used for: Diabetes
Est. 2026 sales: $4.9 billion

Eli Lilly landed a one-two punch on our most anticipated drug launch list this year.

Its Alzheimer’s disease asset donanemab took the top spot with $6 billion in estimated sales by 2026, and it’s also taking second place with its diabetes hopeful tirzepatide, which Evaluate Vantage reckons could be bringing in $4.9 billion by the middle of the decade.

This is much firmer market territory for Lilly compared to Alzheimer’s, given its long history in diabetes. And, like much of its competitive life in this disease, it’s going head-to-head against Danish rival Novo Nordisk.

Tirzepatide works as a dual GIP and GLP-1 agonist and has been acing

trials left and right over the past few years, helping Type 2 diabetes patients keep their blood sugar levels and weight down. It’s biggest win came last year when it beat Novo Nordisk’s GLP-1 blockbuster, Ozempic, in a direct head-to-head study.

In the phase 3 SURPASS-2 trial, the readout was clear: In terms of

reducing blood sugar levels and body weight, Lilly’s drug at all three doses tested was better than Novo’s GLP-1 drug at its highest approved dose.

RELATED: Novo Nordisk’s semaglutide set to tackle obesity with hotly-anticipated FDA green light

As analysts noted at the time,

however, the differences between the two drugs were not huge,

but the size of tirzepatide’s benefit over Novo’s entrenched Ozempic

could make all the difference. “I still question usage of a dual agonist if efficacy is only slightly better,

” Bernstein analyst Wimal Kapadi told Fierce Pharma last March when the head-to-head data first came out.

In his investor note, fellow Bernstein analyst Ronny Gal said tirzepatide’s edge was “likely not sufficient to drive the transformation of the GLP-1 market,” so Lilly will need to work hard to win over this skepticism.

Ozempic already makes around $3.4 billion a year and is set to reach a peak of about $8 billion. It has racked up more indications since its initial approval, including obesity, where it is marketed as Wegovy.

Lilly, however, is going all in. The pharma already has a sizable diabetes commercial team in place thanks to its repertoire of insulins plus GLP-1 and SGLT2 meds Trulicity and Jardiance, respectively. And, while the company expects a diabetes indication first, it’s also eyeing a potential use in obesity to challenge Wegovy. buy Adderall 30mg Without Prescription Overnight Shipping.

Data for its obesity drive will be out in April. At the recent J.P. Morgan Healthcare Conference, Lilly CEO Dave Ricks said the company was mulling the idea of splitting the branding of tirzepatide into diabetes and obesity, as Novo had done, and marketing the pair separately.

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