2021 has already witnessed many eventful FDA approvals. Not even the pandemic could stop biopharma’s historic ability to push prospects over FDA’s finish line.
From Biogen’s historic and controversial speedy nod for Aduhelm in Alzheimer’s disease to Amgen’s closely watched approval for Lumakras, the year has indeed been great so far in the pharma industry.
But the race is far from over. Aiming to close out 2021 with FDA nods stand four possible blockbusters from the likes of UCB, Pfizer, Argenx and Roche. Those drugs together could generate approximately $7.1 billion in sales by 2026 based on Industry estimates.
Here they are:
Sitting comfortably on the top spot in the list of potential blockbusters awaiting FDA decision this year is Argenx’s Efgartigimod in myasthenia gravis (gMG), an autoimmune disease that causes loss of muscle function. The med is slated for a December 17 decision date.
If approved, Efgartigimod would become the first anti-neonatal Fc receptor (FcRn) drug to secure FDA approval. According to SVB Leerink’s estimates, the med rake in up to $25 billion in U.S. sales by 2030.
As for Argenx, it is expected that Efgartigimod would bring in at least $3 billion in sales by 2026. The Belgian firm believes it will have a three-year head start against many heavyweight FcRn competitors, such as UCB and AstraZeneca’s Alexion Pharmaceuticals and Johnson & Johnson’s Momenta Pharmaceuticals.
Efgartigimod is aimed at blocking FcRn, a protection receptor of immunoglobulin G (IgG). That approach is believed to reduce the pathogenic IgG antibodies found in many autoimmune ailments.
UCB’s Bimekizumab faces stern competition ahead if the psoriasis monoclonal antibody achieves an FDA approval come its October 15 decision date.
If granted the agency's nod, the anti-IL-17A and IL-17F injection will be in the market with evidence already in hand that it can compete favourably with top heavyweights from Novartis and Johnson and Johnson. It is anticipated to rake in up to $2 billion in sales by 2026.
In two separate late-stage trials, Bimekizumab managed to triumph over J&J’s megablockbuster Stelara and Novartis’ Cosentyx when it came to clearing moderate to severe plaque psoriasis patients’ skin.
UCB may however face some hurdles outside the clinic. There's a number of concerns that the crowded psoriasis market, which also includes Amgen's Otezla, AbbVie's Skyrizi and Humira, and Eli Lilly's Taltz could defeat Bimekizumab with their superior marketing budgets.
Amid the pandemic, Bayer and Regeneron survived the storm with their blockbuster eye drug Eylea and even managed to increase their med’s market share as a result.
Currently, Roche is aiming to tip the scale back in its direction with its up-and-comer Faricimab as the FDA considers decisions in wet age-related macular degeneration (AMD) and diabetic macular edema (DME), slated for the year’s end.
The Swiss pharma has demonstrated that Faricimab can at least compete with the world's sixth best-selling drug in 2020 in the clinic. Roche confirmed in four phases 3 trials that the bispecific antibody, which targets VEGF and Ang2, didn't do worse than Eylea despite most patients taking it during longer dosing intervals.
Faricimab's sales by 2026 are put at $1.1 billion, far less than what Eylea is currently bringing in.
Now that the federal regulators have finally drawn the curtains on its months-long safety investigation into Pfizer's Xeljanz, a series of JAK decisions is awaiting the FDA's nod. That includes one for Pfizer's other atopic dermatitis med, Abrocitinib.
However, it is not certain how well Abrocitinib would fare given that initial inquiries turned up unfavorable results that have already reverberated throughout the JAK class. Recently, the FDA outlined new heart safety and cancer warnings for Xeljanz, Lilly’s Olumiant and AbbVie’s Rinvoq, and some analysts anticipate a similar warning could be in the offing for Abrocitinib, too.
Abrocitinib’s sales by 2026 could reach $1 billion based on estimates.