The FDA recorded only 37 new drug approvals in 2022, down from an annual average of 51 since 2017. After having to retract its contentious 2021 approval of Biogen’s Aduhelm Alzheimer’s disease medication, has the FDA grown timid?
The incident caused vibrations throughout the sector and even led to a government investigation of the FDA’s expedited clearance process. Given that the agency disregarded the recommendations of a group of impartial experts who felt Aduhelm was unqualified, it didn’t look well for the organisation.
The FDA took more methodical action when faced with a similar dilemma with Amylyx’s ALS medication this year, postponing its decision by six months before finally approving Relyvrio in September after the firm presented more solid trial results.
In 2022, were more medications rejected? Despite previous FDA Commissioner Scott Gottlieb’s efforts, the agency does not publish complete response letters (CRLs), leaving it to the industry to disclose information. However, certain news organisations in the industry do make an effort to watch CRLs, and there is some evidence to indicate that the FDA has tightened the screws.
Pink Sheet Pharma Intelligence reports that during the first half of 2022, there were 19 green lights compared to 14 CRLs, for an approval rate of 57.6%. According to Evaluate, there were 50 nods in 2021 compared to 25 CRLs (66.7%). Between the middle of June and the middle of August, a two-month period, the FDA did not approve any new medications. And it’s not like approvals are often slow at that time of year. For instance, the government authorised eight new medications in 2021 in the same period.
If not for a late rush of five in a stretch of seven days immediately before and after Christmas Day, there would have been lesser clearances in 2022.
Maybe the low number of nods is only a cyclical blip on the radar, like in 2016, when there were just 22 nods between the years when 45 (2015) and 46 (2017) were given out. Bristol Myers Squibb rose to the top of the list of businesses last year that were successful in winning over the FDA. In 2022, it received three additional approvals than any other company, each with a $4 billion peak sales potential.
Bluebird Bio, another firm that made a lot of money in 2022, saw two gene therapies—Skysona and Zynteglo—approved a month apart. Bluebird caused a stir when it set the one-time treatments’ prices at $3 million and $2.8 million, respectively, after they were approved.
However, CSL Behring and uniQure outdid them in November by charging $3.5 million for their recently approved gene therapy, Hemgenix.
What other significant approvals took place in 2022? The approval of Mounjaro by Eli Lilly could be a game-changer for patients with diabetes and obesity, not to mention the financial bonanza it could bring the business as it competes with Novo Nordisk’s Ozempic and Wegovy. Amvuttra, a gene silencer to treat familial ATTR amyloidosis, was given important approval by the FDA. By 2026, it is anticipated that sales of the medication will reach $1.7 billion, making it a blockbuster drug.
The multiple myeloma medicine Carvykti from Johnson & Johnson and Legend is also anticipated to enter the sudden-blockbuster orbit.
Because this data cites approvals for biologic therapies and vaccines but eliminates diagnostic imaging agents, which are included on the FDA’s list, the figures for the yearly roundup often differ significantly from the numbers for the FDA’s official list.
