FDA push­es eczema de­ci­sion for Eli Lil­ly's Olu­mi­ant, Pfiz­er's abroc­i­tinib back 3 months — rais­ing more ques­tions for the JAK class

The FDA re­view ex­ten­sions for JAK in­hibitors are stack­ing up.

Af­ter Eli Lil­ly and In­cyte dis­closed late Tues­day that their sup­ple­men­tal NDA for Olu­mi­ant in mod­er­ate to se­vere atopic der­mati­tis was hit with a 3-month de­lay, Pfiz­er re­vealed ear­ly Wednes­day that its ex­per­i­men­tal abroc­i­tinib is meet­ing the same fate. With Olu­mi­ant, the agency need­ed time to “re­view ad­di­tion­al da­ta analy­ses sub­mit­ted by Lil­ly in re­sponse to re­cent in­for­ma­tion re­quests from the FDA,” ac­cord­ing to a state­ment. Pfiz­er didn’t spec­i­fy a rea­son in its re­lease.

In ad­di­tion, the agency is al­so knock­ing back by 3 months a re­view of Pfiz­er’s Xel­janz for the treat­ment ac­tive anky­los­ing spondyli­tis.

The set­back puts Lil­ly and Pfiz­er in the same boat as Ab­b­Vie, which re­vealed days ago that reg­u­la­tors asked for an up­dat­ed ben­e­fit-risk pro­file of its JAK in­hibitor Rin­voq, push­ing their PDU­FA date to Q3 of 2021.

Safe­ty con­cerns with JAK in­hibitors are not new. In fact, fol­low­ing a rocky de­vel­op­ment path that in­volved an ini­tial re­jec­tion and re­stric­tions in dos­ing, Olu­mi­ant’s ini­tial ap­proval in rheuma­toid arthri­tis came with black box warn­ings on height­ened risks for se­ri­ous in­fec­tions, ma­lig­nan­cy and throm­bo­sis. Rin­voq sports a sim­i­lar la­bel.

The is­sues came to the fore again ear­li­er this year, when Pfiz­er an­nounced that its drug, Xel­janz, has failed the six-year safe­ty study man­dat­ed by the FDA.

Across 4,362 pa­tients, those who re­ceived ei­ther a low or high dose of Xel­janz ex­pe­ri­enced more ma­jor car­dio­vas­cu­lar events — such as stroke and heart at­tack — than those on Hu­mi­ra or En­brel. They al­so had high­er rates of can­cer, with Pfiz­er fail­ing to hit non-in­fe­ri­or­i­ty on both pri­ma­ry end­points.

Ilya Yuf­fa

Ilya Yuf­fa, pres­i­dent of Lil­ly Bio-Med­i­cines, says they stand by the ef­fi­ca­cy of Olu­mi­ant. The drug had scored wins in mul­ti­ple late-stage stud­ies in atopic der­mati­tis, beat­ing cor­ti­cos­teroids and place­bo in clear­ing eczema.

More re­cent­ly, it’s al­so gained promi­nence as the FDA grant­ed emer­gency use au­tho­riza­tion to a com­bi­na­tion of Olu­mi­ant and Vek­lury (remde­sivir) for hos­pi­tal­ized Covid-19 pa­tients who need sup­ple­men­tal oxy­gen, ven­ti­la­tors or life sup­port.

But its uti­liza­tion in atopic der­mati­tis has al­ways been ques­tioned. SVB Leerink an­a­lyst An­drew Berens pre­vi­ous­ly pre­dict­ed that it will play a “mi­nor role” in the dis­ease:

Giv­en the dom­i­nance of (Re­gen­eron’s) Dupix­ent in the mod­er­ate and se­vere AD mar­ket and known safe­ty risks of in­fec­tions, ma­lig­nan­cies, and throm­bo­sis with oral JAK in­hibitors, we be­lieve oral, sys­temic JAK in­hibitors may not cap­ture a mean­ing­ful por­tion of the AD mar­ket. While this pro­file rep­re­sents lim­i­ta­tions of the JAK class for sys­temic ther­a­py, we be­lieve this could open the door for a greater role for top­i­cal JAK us­age, which could be pre­scribed in con­junc­tion with non-JAK sys­temic treat­ment.

In­cyte, which had ini­tial­ly come up with the drug and al­lied with Lil­ly in ex­change for $90 mil­lion up­front back in 2009, has pulled out of co-fund­ing the de­vel­op­ment but con­tin­ues to be el­i­gi­ble for roy­al­ties on sales.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

Just as first Lu­cen­tis biosim­i­lar wins ap­proval, Roche snags an OK for an eas­i­er route of ad­min­is­tra­tion

It’s been a month since the FDA cleared the first biosimilar to Roche’s blockbuster wet age-related macular degeneration (AMD) drug ranibizumab. But the pharma giant isn’t going down without a fight.

Roche’s Genentech got approval on Friday for a new ranibizumab administration route that will allow wet AMD patients to ditch their current monthly injections and opt instead for as few as twice-annual treatments.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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