Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Flori­da Gov. Ron De­San­tis is try­ing so hard to politi­cize the FDA and de­mo­nize the fed­er­al gov­ern­ment that he en­tered in­to an al­ter­nate uni­verse on Mon­day evening in de­scrib­ing a re­cent FDA ac­tion to re­strict the use of two mon­o­clon­al an­ti­body, or mAb, treat­ments for Covid-19 that don’t work against Omi­cron.

With­out fur­ther ado, let’s break down his state­ment from last night, line by line, ad­jec­tive by ad­jec­tive.

First, he calls the FDA move “sud­den and reck­less,” and, “abrupt and uni­lat­er­al.”

In re­al­i­ty, Re­gen­eron (more be­low) and Eli Lil­ly — both for-prof­it com­pa­nies that have made bil­lions from these mAbs and would put up a fight if there was a fight to be had — back the FDA’s de­ci­sion to halt the use of their prod­ucts. They’ve al­so been up­front about the fact that their mAbs don’t work against Omi­cron, which now ac­counts for vir­tu­al­ly every new Covid case in the US. The Na­tion­al In­sti­tutes of Health al­so up­dat­ed its guid­ance on the mat­ter, say­ing the same, and so did every­one else who’s fol­low­ing along.

Then De­San­tis claims the FDA move was made “with­out a shred of clin­i­cal da­ta,” and lat­er in his state­ment he refers to it as “clin­i­cal­ly un­sup­port­ed.” In­deed, the FDA has made many de­ci­sions through­out the pan­dem­ic with­out clin­i­cal da­ta. But in this case, no one needs to run a clin­i­cal tri­al to un­der­stand these mAbs don’t work against Omi­cron.

A Re­gen­eron spokesper­son ex­plained this very sim­ply via email:

The orig­i­nal RE­GEN-COV an­ti­body cock­tail has been ad­min­is­tered to mil­lions of peo­ple, and we are ex­treme­ly proud of the crit­i­cal role this med­i­cine has played dur­ing the pan­dem­ic. How­ev­er, it does not work against Omi­cron in lab tests, which tells us that un­for­tu­nate­ly it is al­so not go­ing to work in peo­ple in­fect­ed with this vari­ant. Ac­cord­ing to the CDC, over 99% of COVID-19 cas­es in the U.S. are now caused by the Omi­cron vari­ant, and thus we be­lieve the FDA’s de­ci­sion to amend the Emer­gency Use Au­tho­riza­tion was ap­pro­pri­ate at this time.

Flori­da Lt. Gov. Jeanette Nuñez lat­er in­cor­rect­ly refers to the mon­o­clon­al an­ti­body treat­ment as Re­gen­eron (Re­gen­eron is the com­pa­ny that makes the cock­tail), and the state­ment says that this FDA de­ci­sion “was made sole­ly by Biden’s Food and Drug Ad­min­is­tra­tion (FDA) with­out ad­vance warn­ing to states or health providers and with­out clin­i­cal da­ta to sup­port the de­ci­sion.”

If Flori­da has any­one who tunes in­to the week­ly calls from HHS Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse on Covid-19 treat­ment dis­tri­b­u­tion, then De­San­tis’ ad­min­is­tra­tion would’ve known this was com­ing, as both mAbs were a fre­quent top­ic of con­ver­sa­tion over the last sev­er­al calls.

Mount Sinai Hos­pi­tal in New York and oth­ers al­so stopped ad­min­is­ter­ing these mAbs in late De­cem­ber, which came as the com­pa­nies made their an­nounce­ments that the mAbs don’t work against Omi­cron.

But Re­gen­eron, which al­so stressed that it will “con­tin­ue to work close­ly with the FDA,” and oth­ers are still hard at work on oth­er an­ti­body and an­tivi­ral can­di­dates that will need to be test­ed in hu­mans to ob­tain new EUAs.

Un­til then, Flori­da and every oth­er state will have to make do with a short sup­ply of the GSK mAb (not men­tioned by De­San­tis), the Pfiz­er and Mer­ck an­tivi­rals, Gilead’s remde­sivir, and the As­traZeneca pro­phy­lac­tic mAb. It’s not a per­fect sit­u­a­tion, but no one knew what Omi­cron would look like be­fore it ar­rived.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.