House com­mit­tees kick off in­ves­ti­ga­tion in­to how Bio­gen's Aduhelm won ap­proval

Two key House com­mit­tees — on Over­sight and Re­form, and En­er­gy and Com­merce — have now of­fi­cial­ly opened their own in­ves­ti­ga­tion in­to the ap­proval of Bio­gen’s new Alzheimer’s drug Aduhelm by ask­ing the com­pa­ny for a va­ri­ety of dif­fer­ent in­ter­nal and ex­ter­nal doc­u­ments and com­mu­ni­ca­tions re­lat­ing to as­sess­ments of the drug’s safe­ty, ef­fi­ca­cy, or clin­i­cal ben­e­fit.

The com­mit­tees are specif­i­cal­ly tar­get­ing the way in which the FDA used the ac­cel­er­at­ed ap­proval path­way to sign off on Aduhelm, de­spite not ques­tion­ing its pan­el of out­side ex­perts (three of whom have since re­signed) on whether such an ac­cel­er­at­ed ap­proval would be ap­pro­pri­ate.

To do that, they’re seek­ing doc­u­ments from Bio­gen re­lat­ing to the use of amy­loid be­ta plaque re­duc­tion as a sur­ro­gate end­point for the treat­ment of Alzheimer’s dis­ease, in­clud­ing whether such plaque re­duc­tion pre­dicts ef­fi­ca­cy in treat­ing cog­ni­tive de­cline. They’re al­so seek­ing fur­ther doc­u­ments on the drug’s price and how Bio­gen came to its de­ter­mi­na­tion on the price, giv­en that ICER said a fair price would be be­tween $3,000 per year — if the drug is not as ef­fec­tive as promised — to $8,400, if it is.

Frank Pal­lone

“We are con­cerned by re­ports of an atyp­i­cal ap­proval process for Aduhelm amid sig­nif­i­cant ques­tions about the drug’s clin­i­cal ben­e­fit, and the steep $56,000 an­nu­al price tag, which will have se­ri­ous im­pli­ca­tions for se­niors, fed­er­al health care pro­grams, and fu­ture Alzheimer’s re­search,” Rep. Frank Pal­lone (D-NJ), chair­man of the E&C com­mit­tee, and Rep. Car­olyn Mal­oney, chair of the Com­mit­tee on Over­sight and Re­form, said in a state­ment.

Car­olyn Mal­oney

As Bio­gen may have turned to some back­door deal­ings with the FDA as part of ear­ly ef­forts to get Aduhelm across the fin­ish line, the com­mit­tees are seek­ing the dates, times, lo­ca­tions, at­ten­dees, and any notes or min­utes tak­en of all calls and in­for­mal and for­mal meet­ings or dis­cus­sions among FDA of­fi­cials and rep­re­sen­ta­tives of Bio­gen.

News of this con­gres­sion­al in­ves­ti­ga­tion co­in­cides with a sep­a­rate in­ves­ti­ga­tion from HHS’ In­spec­tor Gen­er­al, at the re­quest of act­ing FDA com­mis­sion­er Janet Wood­cock, and FDA’s re­cent de­ci­sion to nar­row the drug’s la­bel as part of an at­tempt to calm at least some of its fiercest crit­ics.

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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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.”

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.

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. 

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.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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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.