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This year has already witnessed a handful of memorable FDA approvals. And if one thing’s clear, the pandemic hasn’t slowed biopharma’s ability to push prospects over the agency’s finish line.

There’s been Biogen’s historic and controversial accelerated approval for Aduhelm in Alzheimer’s disease. That’s not to mention Amgen’s closely watched nod for Lumakras, the first lung cancer treatment to target what was once considered “undruggable” KRAS mutations.

But the race isn’t over yet. Looking to close out 2021 with FDA approvals stand four potential blockbusters from the likes of Argenx, UCB, Pfizer and Roche, according to Evaluate Pharma. Those meds combined are worth roughly $7.1 billion in sales cumulatively by 2026, according to Evaluate’s estimates.

Another heavy-hitting hopeful in Evaluate’s mid-year report, Ascendis Pharma’s long-acting growth hormone lonapegsomatropin-tcgd, nabbed its own go-ahead in late August. Now dubbed Skytrofa, that drug is expected to rake in $1.5 billion in sales by 2026.

Scoring an FDA approval isn’t a sure thing for the remaining contenders. For one, Pfizer’s abrocitinib could face additional hurdles now that the agency has chalked up new safety warnings for a handful of JAK inhibitors following its investigation into Xeljanz. Other pipeline prospects, such as UCB’s bimekizumab and Roche’s faricimab, will almost certainly face fierce rivals if they win the agency’s blessing.

Here’s a look at most valuable outstanding FDA decisions remaining in 2021, according to Evaluate:

Efgartigimod
Taking the top spot for the most lucrative remaining FDA decision this year is Argenx’s efgartigimod in myasthenia gravis (gMG), an autoimmune disorder that leads to loss of muscle function. The drug is up for a Dec. 17 decision date.

If approved, efgartigimod would become the first anti-neonatal Fc receptor (FcRn) med to cross the agency’s finish line. Its prize? The first crack at a market that could be worth up to $25 billion in U.S. sales by 2030, according to SVB Leerink’s estimates.

As for Argenx, Evaluate sees efgartigimod bringing in $3 billion in sales by 2026. The Belgian company guesses it will have a three-year head start against some heavyweight FcRn competitors, such as Johnson & Johnson’s Momenta Pharmaceuticals, UCB and AstraZeneca’s Alexion Pharmaceuticals.

Efgartigimod is designed to block FcRn, a protection receptor of immunoglobulin G (IgG). That method is thought to lower the pathogenic IgG antibodies implicated in several autoimmune diseases.

In MG, efgartigimod sits at the FDA’s doorstep after posting promising late-stage trial data that showed it alleviated symptoms far better than placebo after 26 weeks, the first phase 3 win for an FcRn drug.

Among patients who took efgartigimod and tested positive for acetylcholine receptor antibody—an indicator of MG—nearly 68% responded to the drug compared to just 29.7% of those on placebo, according to the company. Meanwhile, 56.8% of patients responded to efgartigimod for at least eight weeks, which dipped to 34.1% at 12 weeks.

Argenx is also trying to push efgartigimod through five other indications and is under review for gMG in Europe and Japan.

Bimekizumab
UCB’s bimekizumab has tough competition ahead if the psoriasis monoclonal antibody scores an FDA nod come its Oct. 15 decision date.

If granted the agency’s go-ahead, the anti-IL-17A and IL-17F injection will enter the market with proof already in hand that it can top heavyweights from Johnson and Johnson and Novartis. It’s expected to round up $2 billion in sales by 2026, Evaluate estimates.

In two separate, late-stage studies, UCB’s bimekizumab managed to beat out J&J’s megablockbuster Stelara and Novartis’ Cosentyx when it came to clearing moderate to severe plaque psoriasis patients’ skin.

In the trial against Stelara, bimekizumab helped 85% of patients achieve a 90% or greater reduction in the area and severity of psoriasis symptoms at 16 weeks, according to results published in The Lancet last year. Complete skin clearance—indicated by a score of PASI 100—occurred in 59% of patients.

Meanwhile, Stelara helped just half of patients reach the 90% threshold and complete skin clearance. With those results in hand, analysts estimated that bimekizumab’s prospects could grow if the drug managed to do the same against Cosentyx. And it did.

In results published in The New England Journal of Medicine in August, bimekizumab managed to completely clear about 62% of patients’ skin after 16 weeks compared to Cosentyx’s nearly 50% showing. However, bimekizumab was tied to higher rates of mild to moderate oral candidiasis cases, or a fungal infection in the mouth.

To be sure, UCB may face other hurdles outside the clinic. There’s some concern that the crowded psoriasis field, which also includes AbbVie’s Skyrizi and Humira, Eli Lilly’s Taltz and Amgen’s Otezla, could outmaneuver bimekizumab with their massive marketing budgets. And even more rivals may be on the way from Bristol Myers Squibb and Pfizer.

Faricimab
During the pandemic, Bayer and Regeneron weathered the storm with their blockbuster eye drug Eylea and even managed to grow their med’s market share along the way.

Now, Roche is hoping to tip the scale back in its direction with its up-and-comer faricimab as the FDA weighs decisions in wet age-related macular degeneration (AMD) and diabetic macular edema (DME), expected by year’s end.

The Swiss pharma has proven that faricimab can at least match the world’s sixth best-selling drug last year in the clinic. Roche found in four phase 3 trials that the bispecific antibody, which targets VEGF and Ang2, didn’t do worse than Eylea despite the majority of patients taking it during longer dosing intervals.

Across the trials, about half of patients were able to last four months on faricimab compared with two months on Eylea. That could give Roche a much-needed leg up given that the drugs are injected through a patient’s eye.

But it may not be a big enough boost to catch up with Regeneron’s sizable lead. Evaluate pegs faricimab’s 2026 sales at $1.1 billion, far less than what Eylea is currently generating.

Abrocitinib
Now that federal regulators have finally concluded their months-long safety investigation into Pfizer’s Xeljanz, a wave of JAK decisions loom on the agency’s horizon. That includes one for the Big Pharma’s other atopic dermatitis drug, abrocitinib.

But how well abrocitinib fares is now up in the air given that inquiry turned up unfavorable results that have already reverberated throughout the JAK class, analysts wager. The FDA recently pegged new heart safety and cancer warnings for Xeljanz, AbbVie’s Rinvoq and Lilly’s Olumiant, and some analysts expect a similar warning could be coming for abrocitinib, too.

For its part, Evaluate has estimated abrocitinib could reach blockbuster status with $1 billion in sales by 2026. That’s just a third of Pfizer’s own expectations for potential peak revenues.

Regulators have shot down other JAK inhibitors in the past over safety concerns, notably for Gilead’s filgotinib in rheumatoid arthritis. Pfizer nor the FDA have given any indication on whether the investigation could hinder abrocitinib’s ability to cross the finish line.

Nonetheless, abrocitinib has turned up some wins on its way to the agency’s decision desk. In late August, Pfizer said its oral med bested Sanofi and Regeneron’s Dupixent when clearing patients’ itch and eczema symptoms at weeks 2 and 4, although key details surrounding its safety remain unknown.

by Noah Higgins-Dunn

Source: fiercepharma.com