US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two mon­o­clon­al an­ti­body com­bos from Eli Lil­ly and Re­gen­eron are no longer au­tho­rized in the US, and ship­ments to states have ceased be­cause HHS said they are “high­ly un­like­ly” to work against the sweep­ing new vari­ant Omi­cron.

The move by the FDA comes as states like Flori­da have be­come in­sis­tent that the mAbs need to be in­de­pen­dent­ly eval­u­at­ed, al­though the fed­er­al De­part­ment of Health and Hu­man Ser­vices, which has shipped hun­dreds of thou­sands of these two mAbs to states in re­cent weeks, did not ship any this week.

“Ju­ris­dic­tions, providers and pa­tients should be aware that we have more treat­ments that do work against Omi­cron avail­able than ever be­fore, in­clud­ing oral and IV an­tivi­rals in ad­di­tion to the GSK/Vir mon­o­clon­al an­ti­body,” HHS said.

Still, all of the treat­ments re­main scarce with about 200,000 Covid cas­es per day in the US, ac­cord­ing to the CDC. HHS each week on­ly ships about 50,000 cours­es of GSK’s sotro­vimab, 75,000 of As­traZeneca’s Evusheld, and every two weeks about 100,000 cours­es of Pfiz­er’s pill Paxlovid and an­oth­er 400,000 cours­es of Mer­ck’s pill mol­nupi­ravir.

The de­ci­sion to up­date the Lil­ly and Re­gen­eron EUAs fol­lows the NIH’s de­ci­sion to up­date its clin­i­cal guide­lines to rec­om­mend against both treat­ments at this time. Lab stud­ies have re­peat­ed­ly shown that both an­ti­body com­bos have vir­tu­al­ly no ac­tiv­i­ty against Omi­cron, the vari­ant that now ac­counts for near­ly all coro­n­avirus cas­es in the US.

And un­like with Lil­ly’s for­mer mAb bam­lanivimab, which had its EUA re­voked last April, FDA opt­ed to re­vise, rather than re­voke, these two mAb emer­gency use au­tho­riza­tions, while not­ing that, “In the fu­ture, if pa­tients in cer­tain ge­o­graph­ic re­gions are like­ly to be in­fect­ed or ex­posed to a vari­ant that is sus­cep­ti­ble to these treat­ments, then use of these treat­ments may be au­tho­rized in these re­gions.”

Some re­main un­con­vinced, al­though their opin­ions seem more cen­tered on their po­lit­i­cal stance against Biden’s FDA than any­thing re­lat­ed to the da­ta. Tak­ing a swipe at the FDA, Flori­da’s sur­geon gen­er­al Joseph Ladapo told a lo­cal TV sta­tion that Flori­da will not re­ly on “what oth­er peo­ple, or peo­ple that the me­dia la­bels ‘ex­perts’ say.”

Flori­da’s health de­part­ment al­so re­leased a state­ment call­ing the FDA move “abrupt,” say­ing all of its mAb sites will close, and urg­ing cit­i­zens to call the FDA “on why this de­ci­sion was made.” But Re­gen­eron and Lil­ly both made clear last month the mAbs don’t work against Omi­cron.

Flori­da Gov. Ron De­san­tis re­leased his own state­ment, sim­i­lar­ly mak­ing a fuss about the move by FDA, false­ly call­ing it “abrupt and uni­lat­er­al,” even as there’s broad agree­ment that the mAbs don’t work against Omi­cron.

Ac­cord­ing to Kaiser Health News, Flori­da was among the top two states ad­min­is­ter­ing these two mAbs from Jan. 5 through Jan. 18.

While Flori­da may end up fol­low­ing the da­ta (nei­ther Lil­ly nor Re­gen­eron has raised any is­sues with the de­ci­sion from FDA or HHS), Ladapo high­lights the way in which the FDA and oth­er fed­er­al health agen­cies have been un­der­mined through­out the pan­dem­ic, and have con­tin­ued to lose the trust of the Amer­i­can peo­ple.

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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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.”

HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

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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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.

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News.