It is now officially too late to say “Happy new year” to people you’ve not seen since December, but it’s not quite too late to be looking ahead to what 2023 might bring. Which is exactly what Amy Brown and Edwin Elmhirst did in our 2023 Preview webinar recently. If you missed it, it’s now available on demand but for a sneak peak of what they talked about, here are three things we learned in the session.
- The impact of the Inflation Reduction Act (IRA) is all Q and no A
It’s unsurprising that we had a few questions on the IRA in our Q&A section but the “A” section of that is pretty thin at the moment. There are a few companies refining their pipelines and invoking the impending legislation in their explanations, but cynics might wonder if this is really the case. On 1st September the first 10 drugs for Medicare price negotiation are named – Edwin had a go at naming likely candidates – but other than that clear landmark, it’s hard to say what might happen next. The sector is still figuring out what might happen to R&D spend and pipeline prioritisation. In essence, this is a big “watch this space” and the Vantage team certainly will be.
- The accelerated approvals pathway is about to get rocky
At a top line, the FDA approvals for 2022 were down on the 10 year average but delays in at least six projects, which moved into this year, may mean the shortfall is made up quite swiftly. However, the more interesting area is accelerated approvals which have got something of a bad rep in recent years, with the Aduhelm debacle finally forcing change. The FDA has raised the bar and won’t consider this pathway unless a confirmatory trial is already in progress. This could increase the cost of getting a drug to market, potentially causing issues for small players who are in danger of running out of road before confirmation can be reached.
- There is more to life than Alzheimer’s
Yes, there is still a lot of noise around the Alzheimer’s drugs that might make it to market this year but there are still questions to be answered around payer reimbursement which might push the real story in 2024. Shorter term, there will be a lot of eyes on diabetes and obesity. The GLP-1 agonist class is growing strongly and, if the FDA plays nicely, these drugs will be the gift that keeps on giving for some time. With big readouts also due in schizophrenia and cardiomyopathy there are plenty of clinical catalysts lining up for biopharma.
Those were my key takeaways from the session but there was loads more covered. To get all the views and data from Amy and Edwin, grab your headphones and a coffee, and check out the on-demand webinar now. Or dig further into the data in the report which you can find here.