Every new year brings new drug approval hopefuls. However, anticipation is especially high this year, considering renewed optimism for success after the disaster year that was 2020.
Thanks to Evaluate consensus sales estimates, we’ve assembled the top 10 of who’s who and what’s percolating for 2021. Fierce Pharma’s most-anticipated new drug launches of 2021 are ranked based on predicted global sales in 2026.
The candidates come with an assortment of controversies, expectations, pandemic-ending ambitions and even one repeat. However, they’re all potential heavyweights—Evaluate estimates every drug on the list will achieve blockbuster status by 2024, even sooner than our five-year timeline.
Leading the way is the industry’s love-hate Alzheimer’s candidate aducanumab from Biogen and Eisai. The backstory of the drug alone could fill all 10 pages of this special report, but suffice it to say this is one of the most-watched decisions—recently delayed to June—by the FDA in a long time, exclusive of COVID-19 vaccines that is.
Which brings us to number two on the list, Novavax’s COVID-19 candidate. The little biopharma that could is reporting big data that shows upwards of 89% effectiveness against the novel coronavirus. While virus variants will weigh on Novavax much like other vaccine makers, it’s already digging in with booster shot efforts to counter the mutations.
In a first-ever development for the top 10, number six on this year’s list is a repeat. Novartis’ inclisiran was slated for U.S. approval by the end of 2020, but the pandemic tripped up the PCSK9 drug’s timeline.
The FDA issued a surprise complete response letter. Although Novartis characterized the FDA’s concerns as “facility inspection-related conditions” at an Italian plant belonging to its contractor Corden Pharma, its fate remains unclear.
The Swiss drugmaker expects to respond to the FDA’s requests around the second or third quarter, but it’s not clear if the FDA will eventually want to inspect this facility, so “it’s difficult to comment on the timeline from there,” Novartis CEO Nas Narasimhan recently told reporters.
Novartis wasn’t the only 2020 drugmaker on last year’s list that was dealt surprises. Of the other nine hopefuls, various fates awaited. While most of the 2020 anticipated drugs still made the leap to approved drug—switching to digital launches and rejiggering manufacturing—a few did not.
Gilead Sciences, for instance, gave up on its JAK inhibitor filgotinib for rheumatoid arthritis, while BioMarin’s hemophilia A gene therapy valoctocogene roxaparvove remains stalled after the FDA issued a complete response letter.
AstraZeneca and FibroGen blockbuster-to-be anemia drug roxadustat is also still waiting with a new decision review date in March, pushed back from December by the FDA for further clinical data analysis.
It goes without saying the 2021 class will look to dodge similar unrequited fates, but even without a pandemic, we’ll likely look back next year on some of the hype that wasn’t.
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