Fewer approvals in 2022 from cautious FDA

The controversies surrounding Biogen planned new blockbusters aduhelm 2021 has escaped few in the biotech world. The US Food and Drug Administration FDA has faced a lot of criticism after going against its own expert panel and approving the drug, despite the fact that there were doubts about the effect it had on the disease.

In a article the online newspaper speculates FiercePharma in whether the Biogen deal has made the FDA more cautious when it comes to drug approvals. In 2022, a total of 37 drugs received market approval from the FDA, which can be compared to the 51 drugs that have been approved by the agency on average each year since 2017. FiercePharma interprets this as a certain caution on the part of the FDA, exemplified by the case of Amylyxs ALS drugs Relyvrio. In this case, last year, the FDA delayed its decision for six months and did not give the green light until the company presented more conclusive study results regarding the candidate.

However, 2022 is not the first year with a low number of FDA approvals. In 2016, the FDA gave the thumbs up to 22 drugs, compared to 2015 when 45 were approved, or 2017 when the number of approvals was up to 46. The newspaper notes that it is difficult to determine whether the above figures are a sign of whether the FDA has taken a more cautious approach. This is because they do not publish their responses to the companies' applications, so-called complete response letters (CRL), but let the companies themselves make the announcement. It is therefore not entirely easy to find out how many applications have been rejected.

Fewer drugs were approved

However, some analytical firms are trying to keep track of the FDA's response. One of them is Pink Sheet Pharma Intelligence which states that the FDA gave the thumbs up to 19 drugs during the first half of 2022, while 14 were rejected. So just over 57 percent were approved. This can be compared to 2021 where the analysis firm Evaluate states that 50 drugs were approved and 25 were rejected, which corresponds to an approval rate of approximately 67 percent. Whether this is a trend of caution on the part of the FDA remains to be seen.

Multiple blockbuster approvals for Bristol Myers Squibb

When it comes to FDA approval, the 2022 winners were American Bristol Myers Squibb (BMS), which received the green light for three drugs, all of which are said to have blockbuster potential. Among them we find Opdualag, a combination treatment where the checkpoint inhibitor Wonderful combined with the LAG-3 antibody relatlimabOpdualag is seen as BMS's response to the approaching patent expiration of its bestsellers Revlimid, eliquis and Opdivo. You can read more about blockbusters that are close to patent expiration here.

The American pharmaceutical giant expects Opdualag to reach peak sales of approximately USD 4 billion around 2029.

Another BMS drug that received FDA approval in 2022 was Camzyos for the treatment of hypertrophic cardiomyopathy. The drug was the main reason for BMS' acquisition of MyoCardia for USD 13,1 billion in 2020. Again, peak sales of over USD 4 billion are expected sometime around 2029.

Thumbs up for lecanemab

How the FDA chooses to act in 2023 remains to be seen, but we can say that it has started the year with a positive attitude. At the end of last week, the agency gave the thumbs up to the Alzheimer's drug lecanemabThe drug, developed by Swedish BioArctic in association with Eisai and Biogen, has been in the spotlight after the positive Phase III results this fall – welcome news for all those patients suffering from the severe dementia disease. The FDA approval caused BioArtic shares to rise in early trading this week, building on the strong rise that came after the Phase III results. Read more.

Among the upcoming applications for market approval we find, among others, Belgian argenx with the antibody drug Viewpoint. The drug was approved in the US in 2021 for the treatment of generalized myasthenia gravis through intravenous administration, and the company is now seeking approval for subcutaneous administration of the treatment.

Upcoming FDA decisions

In addition to the above examples, BioStock has listed some of the market applications that the FDA has to decide on during the first quarter of 2023.