As a sta­ble of new play­ers sets out to top­ple Dupix­ent’s sta­tus as the reign­ing an­ti­body treat­ment for atopic der­mati­tis, the block­buster’s de­vel­op­ers are mov­ing the goal­posts.

Dupix­ent has aced a Phase III tri­al in­volv­ing 162 chil­dren be­tween 6 months and 5 years old, Sanofi and Re­gen­eron say, be­com­ing the first bi­o­log­ic drug to show ef­fi­ca­cy in this young pop­u­la­tion. When giv­en Dupix­ent on top of stan­dard of care top­i­cal cor­ti­cos­teroids, 28% of pa­tients achieved clear or al­most-clear skin com­pared to 4% of those on place­bo — thus meet­ing the pri­ma­ry end­point.

Sanofi and Re­gen­eron have bet big on the Dupix­ent fran­chise, and an­a­lysts have large­ly ex­pect­ed it to pay off, with Jef­feries once peg­ging peak sales at $12.5 bil­lion.

Core to the pitch for physi­cians will be the fact that even as it clears eczema, the drug doesn’t broad­ly sup­press the im­mune sys­tem, which could be par­tic­u­lar­ly dan­ger­ous for young in­fants.

By bind­ing to IL-4Rα, the drug is de­signed to block sig­nal­ing of the IL-4 and IL-13 path­ways.

“When a child is di­ag­nosed with mod­er­ate-to-se­vere atopic der­mati­tis in the first few months of life, many as­pects of their child­hood can be sig­nif­i­cant­ly im­pact­ed. Par­ents and care­givers are chal­lenged to find safe and ef­fec­tive treat­ment op­tions,” said John Reed, Sanofi’s head of R&D. “Cur­rent­ly, the stan­dard of care for this pa­tient pop­u­la­tion is top­i­cal steroids and oth­er im­muno­sup­pres­sive med­i­cines may be used which can dam­age del­i­cate skin and, if used long-term, po­ten­tial­ly im­pact growth.”

The drug, which is al­ready ap­proved for chil­dren aged 6 or above, al­so met the co-pri­ma­ry end­point out­side of the US, which is 75% or greater over­all dis­ease im­prove­ment from base­line. In the drug arm, 53% hit that thresh­old, ver­sus 11% with place­bo, good for a p-val­ue of p<0.0001.

In­ves­ti­ga­tors al­so spelled out stel­lar num­bers on a hand­ful of sec­ondary end­points, in ad­di­tion to “sig­nif­i­cant­ly im­proved mea­sures” in symp­toms such as sleep, skin pain and oth­er qual­i­ty of life met­rics.

• 70% av­er­age im­prove­ment from base­line in EASI com­pared to 20% im­prove­ment with place­bo (p<0.0001)

• 49% av­er­age im­prove­ment from base­line in itch com­pared to 2% im­prove­ment in place­bo (p<0.0001)

Dur­ing the 16-week treat­ment pe­ri­od, the com­pa­nies added, pa­tients on Dupix­ent were 50% less like­ly to get a skin in­fec­tion — 12% of them had at least one in­fec­tion, com­pared to 24% on place­bo. Over­all, there were 11 in­fec­tions in the drug arm and 34 in­fec­tions in the place­bo arm.

Eli Lil­ly, Pfiz­er, Am­gen and oth­ers are hot in pur­suit of the drug as they seek a slice of the eczema mar­ket for them­selves. But they will first have to crash a sol­id wall of da­ta that Sanofi and Re­gen­eron con­tin­ue to build.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to clar­i­fy the re­sults on skin in­fec­tions.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.