FDA push­es back a re­view date for TG's 'U2' com­bo as the biotech steels it­self for up­com­ing ad­comm

The FDA has pushed back its re­view of TG Ther­a­peu­tics’ U2 com­bo (ubli­tux­imab plus Ukoniq) in pa­tients with chron­ic lym­pho­cyt­ic leukemia and small lym­pho­cyt­ic lym­phoma af­ter the drug­mak­er sub­mit­ted up­dat­ed sur­vival da­ta in Feb­ru­ary the agency deemed a ma­jor amend­ment to its ap­pli­ca­tion, ac­cord­ing to a re­lease.

The agency set a new re­view date of June 25, TG said.

The news wasn’t un­ex­pect­ed giv­en some of TG’s re­cent com­ments. In a state­ment, CEO Michael Weiss had this to say:

As men­tioned on our earn­ings call ear­li­er this week, we be­lieved an ex­ten­sion of the PDU­FA date was a like­ly sce­nario es­pe­cial­ly giv­en the pro­posed tim­ing of the up­com­ing ODAC meet­ing. We hope this ex­ten­sion pro­vides the time need­ed to give prop­er at­ten­tion and re­view to the U2 BLA/sN­DA.

With its re­view date pushed out, TG is now star­ing di­rect­ly at an up­com­ing ad­comm for U2’s ap­pli­ca­tion here, which the FDA called back in No­vem­ber. The agency at the time in­di­cat­ed to the biotech that it had more ques­tions on the OS end­point and safe­ty da­ta in the piv­otal Phase III study un­der­gird­ing its ap­pli­ca­tion.

In an up­date Thurs­day, TG said the FDA had sent a list of po­ten­tial ques­tions for that ad­comm, for which a date still hasn’t been sched­uled. Here’s what the com­pa­ny said could be on the dock­et:

The FDA has no­ti­fied the Com­pa­ny that po­ten­tial ques­tions and dis­cus­sion top­ics for the ODAC in­clude: the ben­e­fit-risk of the U2 com­bi­na­tion in the treat­ment of CLL or SLL, and the ben­e­fit-risk of Ukoniq in re­lapsed/re­frac­to­ry mar­gin­al zone lym­phoma (MZL) or fol­lic­u­lar lym­phoma (FL). In ad­di­tion, as part of the ben­e­fit-risk analy­sis, the over­all safe­ty pro­file of the U2 reg­i­men, in­clud­ing ad­verse events (se­ri­ous and Grade 3-4), dis­con­tin­u­a­tions due to ad­verse events, and dose mod­i­fi­ca­tions, is ex­pect­ed to be re­viewed. The FDA’s con­cern giv­ing rise to the ODAC meet­ing ap­pears to stem from an ear­ly analy­sis of over­all sur­vival from the UNI­TY-CLL tri­al.

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.