PRV Watch

H.R.9699 - Drug Deal Disclosure Act has been introduced to Congress to require release of documents relating to MFN pricing agreements. This includes documentation relating to MFN companies that received a Commissioner’s National Priority Review Voucher. congress.gov/bill/119th-con…

@RxRegA There was a news release on day of approval fda.gov/drugs/news-eve…

FDA’s press release today announcing approval of the first oral PCSK9 inhibitor to lower cholesterol mentions the Commissioner’s Priority Review Voucher Program. While the drug was approved on Wednesday, the lack of an immediate press release led to some early speculation about the absence of any public mention of either the approval itself or the voucher program.

@NedPagliarulo @AlecGaffney Thanks Ned, appreciate you investigating

@PRVWatch @AlecGaffney I think your conclusion is correct @PRVWatch. I'd also note to your point at the top of the thread, $MRK executive Dean Li said back in April that the company planned to PR acceptance of the NDA: merck.com/wp-content/upl…

This is an all time record for FDA approval speed of a novel drug. The drug was approved in only 24 days from completed (rolling) submission. I’ve been wondering why I missed the announcement for the filing…well if i’ve got this right, Merck never got the chance because approval was so quick.

@jamesalts That’s a really good observation, all hands on deck at Merck now I’m sure

@PRVWatch It's so fast Mrk doest even have a now approved site

@AlecGaffney @NedPagliarulo Apols, didn’t mean to pull you in, hadn’t appreciated you’re on pat leave. Hope you and family are doing well.

@PRVWatch I’ve been on parental leave the last few weeks, so I’m a bit out of the loop. If it was 24 days, that would be extraordinarily quick. @NedPagliarulo might be able to check some of our AgencyIQ data.

No press release from the FDA on this which surprises me. @AlecGaffney have I interpreted this wrong???

Here’s the approval letter if any regulatory folks want to check my interpretation: accessdata.fda.gov/drugsatfda_doc…

Merck $MRK receives FDA approval today for Lipfendra (enlicitide) as a treatment to reduce cholesterol (LDL-C). Merck was awarded a Commissioners National Priority Voucher (CNPV) for enclitide, though the press releases from Merck and FDA don’t mention the CNPV program at all.

Topic of my circular going out shortly is why priority review vouchers are denied. The most common reason companies are denied a voucher is that the active drug or active moiety has already been approved

8th approval under the Commissioner’s National Priority Voucher pilot program for Vertex’s Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with sickle cell disease or β thalassemia. Notably, still called ‘Commissioner’s’ program.

Since the first FDA Priority Review Voucher was sold in 2014, PRV sales have generated more than $8 billion.

7 Priority Review Voucher sales announced so far this year with the smaller biotechs opting to monetize their PRVs as soon as possible from it being issued. Prices between $180M - $200M holding strong.

This is the most Priority Review Voucher transaction activity in a single quarter EVER.

Denali Therapeutics $DNLI announced today that they have sold the priority review voucher they were issued in March for $195M . Six of the Seven PRVs issued this year have been sold already, with the last to be likely retained by the company (Regeneron) to redeem themselves.

@AlecGaffney Congrats Alec 😊

Some belated personal news: My wife and I welcomed our first child into the world earlier this month. Everyone is happy and healthy (and wildly sleep deprived). Minimal tweets about the FDA for a while I enjoy some parental leave from POLITICO!

Anyone with expertise relating to HSR Act early termination notices. Seeking some advice/info. DM

Sanofi $SNY receives approval for Tzield (teplizumab) to treat pediatric stage 3 T1D. Sanofi was awarded a Commissioner's National Priority Voucher for this indication but its unclear if this approval was still under the CNPV program as the decision has been delayed for months.

most people in biotech don't even know the PRV exists, but the data are there for anyone who's curious 📊👀 at the current clearing price of ~$200M, it now pays to invest in rare disease drug development the demand for PRVs is going up because pharma is hungry for blockbusters