Look for an end-of-year boost to drug approvals

 An apparent slowdown at the FDA has biopharma fretting. With the sector struggling to beat off a bear market, the last thing downtrodden developers need are regulatory worries.

Extreme concern is probably a bit premature, at least according to Evaluate Vantage’s look at what remains on the cards for 2022. Several important verdicts are due in the final months of the year, with November looking particularly busy.

But the data do point downwards. The FDA’s CDER and CBER divisions greenlit 19 novel medicines in the first half of the year, the slowest six-month period since 2019. For this analysis imaging agents and reagents are removed from the agency’s official lists of new drug approvals, to construct a tally of solely therapeutic agents. 

A number of reasons have been suggested for the apparent pullback. These range from staff shortages at the agency to a tightening of standards post-Aduhelm and the arrival of a new FDA commissioner. It could also just be a blip, of course, like 2016's, when the annual tally dropped below 30.

Evaluate Vantage also identified 22 remaining approval decisions this year for listed developers being tracked by sellside analysts. This list will be far from exhaustive, as many companies keep regulatory progress under wraps, and there are always below-the-radar projects in the works.

If all 22 get a green light there will be 41 novel approvals in 2022. That would represent a slowdown on the last five years, and would also sit below the 10-year average of 48.

 Approval count: 33

It is probably too early to know whether the FDA really is tightening up. Some believe that more complete response letters are being issued, but this is hard to track because the agency leaves disclosure up to developers. Ongoing pandemic travel restrictions have certainly delayed some decisions – the second half of 2021 also saw a drop on the previous six-month periods.

A separate consideration is whether new drug applications have fallen, but the agency only reveals that number sporadically. Numbers disclosed to 2019 suggest that this is unlikely. 

Whatever the reason, should investors be concerned if this slowdown is confirmed at year end? It is certainly a trend that no one would want to see worsening, given wider pressures on developers right now. 

On the cards

As for the big decisions still pending, next month’s verdict on Bristol Myers Squibb’s deucravacitinib has long been one of this year’s biggest. Whether chunky expectations can be met will depend on the label.

November holds at least seven key Pdufa dates, including those for Apellis’s pegcetacoplan and Travere’s sparsentan. Some in the sellside reckons both could go on to become blockbusters. The first gene therapy for haemophilia B, from Uniqure and its partner CSL, could also get the nod in November.

December could be similarly busy, with decisions due on Mirati’s adagrasib and TG Therapeutics’ ublituximab, with a positive outcome far from guaranteed for either. By the end of the year a couple of followers in the anti-PD-(L)1 space are also hoping to arrive in the US: Novartis and Beigene with tislelizumab and Coherus and Shanghai Junshi with toripalimab.

Six of 2022’s 10 biggest potential launches, as things stood back in February, have crossed the finish line. The remaining four are still in with a chance, with deucravacitinib and lenacapivir featuring among the most important still outstanding.

But several of the contenders in the list are looking shaky. TG's ublituximab, Provention Bio's PRV-031 and Mirati's adagrasib all have questions marks hanging over them. If the year does end with a whimper, it might start to feel like biopharma’s years of excess really are ending, and not just on the stock market.

2022's biggest approvals still to come...
Product	Company	Status	2028e sales ($bn)
Intravitreal pegcetacoplan	Apellis	Nov 25 Pdufa for geographic atrophy	2.6
Adagrasib	Mirati	Dec 14 Pdufa for KrasG12C driven NSCLC; EU decision due H1 2023	2.0
Deucravacitinib	Bristol Myers Squibb	Sep 10 Pdufa for psoriasis; EU decision due Q4 2022	1.6
Sunlenca (lenacapivir)	Gilead	Dec 27 Pdufa for resistant HIV (resubmission); EU approved in Aug	1.6
Sparsentan	Travere Therapeutics	Nov 17 Pdufa for IgA nephropathy	0.9
...and those already across the finish line
Mounjaro	Lilly	FDA approved for type 2 diabetes in May; CHMP positive opinion in Jul	7.4
Spikevax	Moderna	Full approvals in US & EU in Jan, to prevent Covid	4.1
Amvuttra	Alnylam	FDA approved for amyloidosis in Jun; CHMP positive opinion in Jul	2.4
Camzyos	Bristol Myers Squibb	FDA approved for cardiomyopathy in Apr; EU decision due Q4 2022	2.3
Vabysmo	Roche	FDA approved for AMD and DME in Jan; CHMP positive opinions in Jul	1.8
Source: Evaluate Pharma. https://www.evaluate.com/vantage/articles/news/policy-and-regulation-nme-approvals/brace-end-year-boost-drug-approvals