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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.