Last Updated on April 30, 2020 by Chris Stang
In these trying times of COVID-19, companies, government agencies, and medical workers are working to provide patients with the medications needed to maintain quality of life, and more importantly, survival. There has been debate as to if the FDA would be able to stick to its target PDUFA action dates. This affects the availability of the drugs for patients, but also the financials of drug companies. Here at MS Money Moves, we utilize our MS Intel section to track upcoming PDUFA dates, helping investor be aware of important catalysts for biopharma companies. We have taken a look back at the data for the month of April to evaluate if the FDA has been hitting it goal action dates, and how early these approvals or denials are being announced.
All Applications
Within our data set, the FDA action was announced an average of 26 days prior to the target action date. Now, this is largely inflated by a few approvals under special circumstances, which will be addressed here shortly. What is likely more telling is the median, which revealed an action announced on median 3 days prior to the target date. There were only two actions that were announced after the target data, which included one denial (Complete Response Letter [CRL]) and an approval in which the target date was over the weekend. Overall, I believe that this data shows that even though times are hard with COVID-19, the FDA is still meeting their target action dates, and even more so, are handing down their opinions ahead of target dates.
Special Circumstances
As alluded to previously, there were several approvals that occurred quite early, resulting in the inflated early average action date. The first is the approval of Seattle Genetics’ (SGEN) tucatinib for HER2 positive breast cancer. This occurred under the FDA’s Real Time Oncology Review (RTOR) program, which is specifically designed to expedite the review of applications. This approval came 125 days early, which is clearly an abnormality. A second early approval was for Immunomedics’ (IMMU) sacituzumab govitecan. This drug previously received a CRL due to manufacturing issues and not clinical data. Thus, this application and review focused on the manufacturing, and not a complete review as would be commonly undergone. The importance of this discussion here is that while at face value, some approvals appear to coming quite early, but your standard upcoming PDUFA date is likely to occur close to the target date in the absence of extenuating circumstance.
New Chemical Entities
Finally, lets take a look at the applications for new chemical entities (NDAs and BLAs), while excluding the aforementioned unique instances. The average action for these companies occurred 7.5 days ahead of the target date, with a median being one day early. Again, this information aims to show that NDA or BLA applications seeking the first approved indication for a product are receiving the FDA’s ruling very close to the target date.
Conclusions
At the present time, the April data suggests that the FDA is still hitting their target action dates for new chemical entities and supplemental applications. This is encouraging to patients waiting for essential medications, but also helps investors know what to expect for their companies’ upcoming PDUFA dates. We will continue monitor these metrics and share them out as deemed appropriate.
I/we long IMMU.
