Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up – at least in terms of the volume of activity. First let’s look at the approval of new molecular entities, and then at the number of Advisory Committee meetings being held, and compare them to the first half of 2022.
New Molecular Entity (NME) Approvals – These approvals are an important indicator of innovation coming from test tube to patients. Last year was not looking particularly good at mid-year, with only 16 NME approvals by June 30 and only 37 for the entire year – the least number since 2016. This year, however, with 26 NME approvals at mid-year. there has been a significant uptick – more in fact than any other previous mid-year check-in with the exception of 2021. It looks like we are off to a good start, and if annualized would mean that we would possibly see 52 NME approvals for the year, which is on par with the years 2019 – 2021 (2022, as you can see in the chart below was a bit anemic). But in fact, as can be seen in previous years such as 2019, 2018 and 2015, the mid-year tally (in red) is not always predictive of what we may see by year’s end (in blue). The second half could move either faster or slower. There are still many decisions and publicly available PDUFA dates with many novel treatments among them, including investigative treatments for sickle cell disease and ALS.
AdComms and Approval Votes Are Up – In addition to NME approvals, there have been an increased number of FDA Advisory committees held to discuss new treatments. That could indicate (1) more new medicines up for considerations and/or (2) more situations where FDA feels it needs the advice of consultants in the course of deliberations.
By my count, during the first half of 2022 there were only 4 advisory committee meetings held to discuss new drug applications (NDAs), compared to 17 held during the first half of 2023 – which is kind of a whopping 300 percent increase. In fact, by mid-2023, there were 17 AdComms held, outpacing the number held during all of 2022 when there were 14 for the year (19 had been scheduled, but 5 of them did not take place).
But there is another important contrast between last year and this and that is in regard to outcomes – of the 4 meetings held in the first half of 2022, the vote was negative in 100 percent of them. In fact, in 2022, there were only 4 approval recommendations out of the 14 meetings held that year. In other words, 71 percent of the 2022 outcomes were negative. By contrast, in 2023, of the 17 meetings held to discuss NDAs during the first half of the year, the vote was positive in nearly all of them – 16 recommendations for approval – or 94 percent approval recommendations – also a rather eye popping reversal in trend.
Individual AdComm Frequency – The AdComm that met more than any other was the Antimicrobial Microbial Drugs Advisory Committee with a total of four meetings, followed by the Oncologic Drugs Advisory Committee with 3, and the Peripheral and Central Nervous System Drugs Advisory Committee with 2 meetings. All the other meetings held during the first half of 2023 – Cellular Tissue and Gene Therapy, Endocrinologic Drugs Advisory Committee, Gastrointestinal Drugs Advisory Committee Obstetrics, Reproductive and Urologic Drugs Advisory Committee, the Psychopharmacologic Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee all had a single meeting. The committee that had the sole negative recommendation was from the Gastrointestinal Drugs Advisory Committee which did not recommend approval for an NDA involving a treatment for pre-cirrhotic liver fibrosis due to NASH.
Other Approvals – Of course, there are many drugs approved that are not NMEs and which do not have Advisory Committee meetings. One last indicator is to review the number of press releases about drug approvals this year compared to last. During the first half of 2022, FDA issued only six press releases about drug approvals compared to 13 during the first half of this year.
There are other approvals not included here that occurred as well. But looking to these indicators – NME approvals, AdComm recommendations and FDA press releases, 2023 is carving its own unique profile. If 2023 continues at this pace, it looks to be shaping up as a banner year for both the volume of FDA advisory committee meetings well as for the proportion and number of approval recommendations.
