FDA chides Am­gen over mis­lead­ing ban­ner ad for Neu­las­ta

In its sec­ond un­ti­tled let­ter of 2021, the FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion raised ques­tions about Am­gen’s mis­lead­ing ban­ner ads for its block­buster bone mar­row stim­u­lant Neu­las­ta.

OPDP notes that cer­tain claims and pre­sen­ta­tions in the ads, which Am­gen said were di­rect­ed at health care pro­fes­sion­als, “cre­ate a mis­lead­ing im­pres­sion re­gard­ing the ben­e­fit of the prod­uct.”

For in­stance, Am­gen says in its ads that there is a sta­tis­ti­cal­ly sig­nif­i­cant high­er risk of febrile neu­trope­nia when Neu­las­ta is ad­min­is­tered via the pre­filled sy­ringe com­pared to its On­pro on-body in­jec­tor. “How­ev­er, the mul­ti­ple lim­i­ta­tions of the cit­ed study pre­clude the draw­ing of such con­clu­sions re­gard­ing the com­par­a­tive risk of febrile neu­trope­nia (FN) in pa­tients tak­ing peg­fil­gras­tim de­pend­ing on de­liv­ery method,” the FDA says.

Among those lim­i­ta­tions is Am­gen’s use of an un­val­i­dat­ed al­go­rithm with un­known per­for­mance char­ac­ter­is­tics and the fact that the study was not bal­anced or con­trolled for po­ten­tial bias, the FDA notes. And while Am­gen does note two lim­i­ta­tions to the study, the agency adds that the men­tions do not mit­i­gate the mis­lead­ing claims and pre­sen­ta­tions in the ban­ner.

Be­cause Neu­las­ta biosim­i­lars have al­so reached the mar­ket, these mis­lead­ing claims may not just be lim­it­ed to those us­ing Am­gen’s prod­uct.

“The above mis­lead­ing claims and pre­sen­ta­tions are par­tic­u­lar­ly con­cern­ing from a pub­lic health per­spec­tive be­cause they could un­der­mine con­fi­dence not just in Neu­las­ta de­liv­ered via PFS but al­so in FDA-li­censed biosim­i­lar peg­fil­gras­tim prod­ucts, which are on­ly de­liv­ered via PFS,” the FDA said.

Am­gen told End­points News in an emailed state­ment that it will work with the FDA to en­sure it’s in com­pli­ance with the reg­u­la­tions. But the com­pa­ny al­so not­ed, “There is a ro­bust body of clin­i­cal and re­al-world ev­i­dence that demon­strates that when used every cy­cle, Neu­las­ta sig­nif­i­cant­ly re­duced the in­ci­dence of febrile neu­trope­nia (FN) as well as FN-re­lat­ed events, in­clud­ing FN-re­lat­ed hos­pi­tal­iza­tion and the use of an­ti-in­fec­tive drugs in pa­tients un­der­go­ing chemother­a­py.”

The use of un­ti­tled let­ters by OPDP has slow­ly be­come a thing of the past, es­pe­cial­ly when com­pared with the num­ber of let­ters is­sued in the late 1990s, when the of­fice rou­tine­ly sent out more than 100 per year. Since 2017, how­ev­er, the agency has on­ly is­sued such un­ti­tled let­ters a hand­ful of times an­nu­al­ly, with 2 com­ing in 2017, 5 in 2018, 7 in 2019, and 2 for each of the last 2 years.

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

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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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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.

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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FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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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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