Bio­gen pulls the plug on its Eu­ro­pean ap­pli­ca­tion for con­tro­ver­sial Alzheimer's drug

In an­oth­er blow to Bio­gen’s con­tro­ver­sial Alzheimer’s drug, the com­pa­ny has de­cid­ed to pull its ap­pli­ca­tion for the drug in Eu­rope af­ter reg­u­la­tors there re­ject­ed it late last year.

In mak­ing the de­ci­sion, the EMA ex­plained how, al­though Aduhelm (ad­u­canum­ab) re­duces amy­loid be­ta in the brain, the link be­tween this ef­fect and clin­i­cal im­prove­ment has not been es­tab­lished.

The FDA fa­mous­ly signed off on the drug last June un­der an ac­cel­er­at­ed ap­proval that al­lows for this con­fir­ma­to­ry clin­i­cal ben­e­fit to be es­tab­lished at a lat­er date, al­though the Cen­ters for Medicare and Med­ic­aid Ser­vices have since fi­nal­ized a de­ci­sion to not pay for use of the Aduhelm out­side of clin­i­cal tri­als, se­vere­ly re­strict­ing any im­me­di­ate sales of the drug.

“This with­draw­al is based on in­ter­ac­tions with the CHMP in­di­cat­ing that the da­ta pro­vid­ed thus far would not be suf­fi­cient to sup­port a pos­i­tive opin­ion on the mar­ket­ing au­tho­riza­tion of Aduhelm(ad­u­canum­ab),” Bio­gen Nether­lands B.V. told the EMA in a let­ter dat­ed April 20. The com­pa­ny pre­vi­ous­ly said it would ap­peal the EMA de­ci­sion.

The EMA al­so pre­vi­ous­ly raised con­cerns about the safe­ty of the drug, when it first rec­om­mend­ed re­ject­ing it back in De­cem­ber, not­ing:

The stud­ies did not show that the med­i­cine was suf­fi­cient­ly safe as im­ages from brain scans of some pa­tients showed ab­nor­mal­i­ties (amy­loid-re­lat­ed imag­ing ab­nor­mal­i­ties) sug­ges­tive of swelling or bleed­ing in the brain, which could po­ten­tial­ly cause harm. Fur­ther­more, it is not clear that the ab­nor­mal­i­ties can be prop­er­ly man­aged in clin­i­cal prac­tice.

Mean­while, the com­pa­ny’s da­ta on how the drug af­fect­ed cog­ni­tion are “con­flict­ed,” the EMA said. One of two iden­ti­cal stud­ies failed; the oth­er showed a small ben­e­fit in the high dose co­hort. These stud­ies “did not show over­all that Aduhelm was ef­fec­tive at treat­ing adults with ear­ly stage Alzheimer’s dis­ease,” EMA said.

Lay­offs at the com­pa­ny have piled up re­cent­ly as it plans $500 mil­lion in cost-cut­ting mea­sures.

Mean­while, the FTC, SEC, FDA, HHS in­spec­tor gen­er­al, and the US House com­mit­tees on Over­sight and En­er­gy & Com­merce are all con­duct­ing in­ves­ti­ga­tions in­to the ap­proval and the close re­la­tions be­tween the FDA and Bio­gen. The con­gres­sion­al in­ves­ti­ga­tion launched last Ju­ly, as rep­re­sen­ta­tives sought from the com­pa­ny a va­ri­ety of dif­fer­ent in­ter­nal and ex­ter­nal doc­u­ments and com­mu­ni­ca­tions re­lat­ing to as­sess­ments of Aduhelm’s safe­ty, ef­fi­ca­cy, and clin­i­cal ben­e­fit.

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.”

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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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.

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.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.