Jen Goldsack, Digital Medicine Society CEO

Ab­b­Vie, Janssen, No­var­tis, Pfiz­er and UCB to joint­ly ad­vance 'dig­i­tal' end­point for atopic der­mati­tis

As the com­pe­ti­tion around the lu­cra­tive atopic der­mati­tis space heats up, Ab­b­Vie, Janssen, No­var­tis, Pfiz­er, and UCB are com­ing to­geth­er in a pre-com­pet­i­tive col­lab­o­ra­tion to ad­vance noc­tur­nal scratch as a “dig­i­tal” end­point for the skin con­di­tion.

The Big Phar­mas are hop­ing to dri­ve the broad­er ac­cep­tance of noc­tur­nal scratch as a mean­ing­ful end­point for atopic der­mati­tis, and for dig­i­tal end­points in gen­er­al.

Pfiz­er re­searchers pub­lished a pa­per in March in a Na­ture part­ner jour­nal, in which they ex­plain how wear­able sen­sors “can pro­vide nov­el, ob­jec­tive mea­sures of night­time scratch­ing and sleep; how­ev­er, many cur­rent ap­proach­es were not de­signed for pas­sive, un­su­per­vised mon­i­tor­ing dur­ing dai­ly life. In this work, we present the de­vel­op­ment and an­a­lyt­i­cal val­i­da­tion of a method that se­quen­tial­ly process­es epochs of sam­ple-lev­el ac­celerom­e­ter da­ta from a wrist-worn de­vice to pro­vide con­tin­u­ous dig­i­tal mea­sures of night­time scratch­ing and sleep quan­ti­ty.”

Pfiz­er faces an in­creas­ing­ly crowd­ed atopic der­mati­tis space as Ab­b­Vie’s block­buster Rin­voq is cur­rent­ly un­der FDA re­view for the in­di­ca­tion, and ac­cord­ing to SVB Leerink biotech an­a­lyst Ge­of­frey Porges, “looks spec­tac­u­lar­ly ef­fec­tive at its high­est dose.” But he said Pfiz­er’s abroc­i­tinib, its next-gen fol­low-up on Xel­janz, “con­tin­ues to look meh.”

The col­lab­o­ra­tion be­tween the com­pa­nies is a bit of an ex­plorato­ry mis­sion too as the FDA has nev­er au­tho­rized or ap­proved any new med­ical prod­ucts on the ba­sis of these dig­i­tal end­points, which are de­fined as end­points that use sen­sors to cap­ture ex­ist­ing mea­sures in a new way, ac­cord­ing to an op-ed by Jen Gold­sack, CEO of the Dig­i­tal Med­i­cine So­ci­ety.

DiMe is help­ing these five bio­phar­ma com­pa­nies in their col­lab­o­ra­tion and be­lieves that dig­i­tal end­points present an op­por­tu­ni­ty to pro­vide “a more mean­ing­ful and com­plete un­der­stand­ing” of pa­tients’ con­di­tions and re­spons­es, and po­ten­tial­ly re­duce the time and cost of bring­ing new ther­a­pies to mar­ket.

But for the FDA, which doesn’t use the term “dig­i­tal end­point,” the chal­lenges of cap­tur­ing pa­tient-re­port­ed out­comes are nu­mer­ous, and can in­clude every­thing from the in­stru­ment used ap­pro­pri­ate­ly in the tri­al, to how the spon­sor ad­e­quate­ly mea­sured the re­sults, which are of­ten con­veyed in a “score,” and may be dif­fi­cult to un­der­stand the mag­ni­tude of the ben­e­fit, par­tic­u­lar­ly in re­la­tion to safe­ty risks, ac­cord­ing to an FDA pre­sen­ta­tion.

Di­ane Stephen­son, ex­ec­u­tive di­rec­tor of the Crit­i­cal Path for Parkin­son’s, al­so ex­plained some of the con­fu­sion around dig­i­tal end­points at a pa­tient-fo­cused drug de­vel­op­ment work­shop in 2019 at FDA.

“I’ve been told many times that peo­ple think that if you use an FDA cleared de­vice or an ap­proved de­vice –­ 510(k) cleared de­vice — then that au­to­mat­i­cal­ly means that that de­vice will be ac­cept­ed as an end­point, a dig­i­tal end­point in a tri­al, so that’s in­cor­rect,” she said.

“As we’ve heard to­day many times that de­f­i­n­i­tions of how to de­fine what would be achieved with an end­point are quite unique,” she not­ed, while point­ing to the FDA’s for­mal qual­i­fi­ca­tion process for drug de­vel­op­ment tools. “So this is just some re­al­ly im­por­tant ground­ing that we try to con­tin­ue to re­mind, es­pe­cial­ly spon­sors who are se­lect­ing dig­i­tal tools for use pri­mar­i­ly as ex­plorato­ry end­points, but their goal re­al­ly is a dig­i­tal end­point in a tri­al,” Stephen­son said.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).