Richard Gonzalez, AbbVie CEO (Chris Kleponis via AP Images)

Ab­b­Vie adds de­pres­sion in­di­ca­tion to Vray­lar's la­bel months af­ter Gon­za­lez touts $4B+ peak sales po­ten­tial

Ab­b­Vie CEO Richard Gon­za­lez wants to bring Vray­lar to new heights. On Fri­day, reg­u­la­tors set the next phase of his plan in mo­tion.

The FDA ap­proved Vray­lar, al­so known as cariprazine, as an add-on ther­a­py for adults with ma­jor de­pres­sive dis­or­der (MDD), one of the most com­mon men­tal dis­or­ders in the US. That marks Vray­lar’s fourth in­di­ca­tion be­hind schiz­o­phre­nia, the acute treat­ment of man­ic or mixed episodes in those with bipo­lar I dis­or­der, and de­pres­sive episodes in bipo­lar I pa­tients.

When Ab­b­Vie filed its sup­ple­men­tal new drug ap­pli­ca­tion (sN­DA) back in Feb­ru­ary, Gon­za­lez pre­dict­ed an in­di­ca­tion in MDD would push peak sales past $4 bil­lion. The drug earned $1.7 bil­lion in 2021, com­pris­ing al­most one third of Ab­b­Vie’s neu­ro­science rev­enue.

Ab­b­Vie’s now tout­ing the drug as an op­tion for pa­tients who’ve made some progress on at least one oth­er an­ti­de­pres­sant — but no more than three — yet con­tin­ue to suf­fer. About 1 in 5 adults will ex­pe­ri­ence MDD in their life­times, ac­cord­ing to Ab­b­Vie.

“Fifty or more per­cent of pa­tients can have an in­ad­e­quate re­sponse to their an­ti­de­pres­sant, and those pa­tients de­serve more,” said Ken Kramer, as­so­ciate VP and ther­a­peu­tic area lead of psy­chi­a­try, US med­ical af­fairs at Ab­b­Vie.

Vray­lar, ini­tial­ly co-de­vel­oped by Al­ler­gan and Gedeon Richter, works by re­bal­anc­ing dopamine and sero­tonin to im­prove mood and be­hav­ior. How­ev­er, the path to ap­proval hasn’t ex­act­ly been smooth.

At 6 weeks, pa­tients on a 1.5 mg dose of Vray­lar plus an an­ti­de­pres­sant showed a sta­tis­ti­cal­ly sig­nif­i­cant change from base­line in MADRS score, a com­mon scale used to mea­sure the sever­i­ty of de­pres­sive episodes, com­pared to an an­ti­de­pres­sant alone, ac­cord­ing to Ab­b­Vie. How­ev­er, a 3 mg dose of the drug missed sta­tis­ti­cal sig­nif­i­cance at 6 weeks, with a p-val­ue of 0.0727. In a sec­ond study, Ab­b­Vie re­port­ed a sta­tis­ti­cal­ly sig­nif­i­cant change from base­line to week 8 in pa­tients who took an an­ti­de­pres­sant plus Vray­lar dos­es be­tween 2 and 4.5 mg dai­ly (with a mean dose of 2.6 mg).

Ab­b­Vie sub­mit­ted an sN­DA based on the “to­tal­i­ty” of the da­ta, and reaf­firmed its con­fi­dence in the drug ear­li­er this year. Pa­tients tak­ing Vray­lar for MDD will start on 1.5 mg per day, and can move up to 3 mg a day af­ter a cou­ple weeks if nec­es­sary.

That wasn’t cariprazine’s first snag in late-stage de­vel­op­ment. Al­ler­gan and Gedeon Richter re­port­ed a Phase III flop in de­pres­sion back in 2016. And in 2017, the FDA is­sued Al­ler­gan a refuse-to-file let­ter on its sup­ple­men­tal ap­pli­ca­tion for cariprazine as a new ther­a­py for neg­a­tive symp­toms as­so­ci­at­ed with schiz­o­phre­nia. At the time, the drug had al­ready been ap­proved for schiz­o­phre­nia and the acute treat­ment of adults with man­ic or mixed episodes as­so­ci­at­ed with bipo­lar I dis­or­der.

How­ev­er, Ab­b­Vie clear­ly likes what it sees. The phar­ma gi­ant ex­tend­ed its col­lab­o­ra­tion with Gedeon Richter back in March, which will in­clude “sev­er­al new chem­i­cal en­ti­ties.”

A 30-day sup­ply of Vray­lar costs just over $1,300. How­ev­er, Ab­b­Vie said cer­tain com­mer­cial­ly in­sured pa­tients can get their first two 30-day re­fills for free — and 30- or 90-day re­fills for as low as $5 — through its VRAY­PAY pro­gram.

Vray­lar isn’t ap­proved for pa­tients with de­men­tia-re­lat­ed psy­chosis. When asked whether Ab­b­Vie plans to pur­sue an ex­pand­ed la­bel for pe­di­atric pa­tients with MDD, Kramer said it’s “still be­ing de­ter­mined.”

“It is a high­ly stig­ma­tiz­ing dis­ease state,” Kramer said. “If you think about it, there’s no stig­ma if you have high blood pres­sure. There’s no stig­ma if you have mac­u­lar de­gen­er­a­tion in your eye. But there’s tremen­dous stig­ma when it comes to pa­tients who are liv­ing with men­tal ill­ness. And we, a very long time ago, de­cid­ed that we were go­ing to stay in this area be­cause these pa­tients de­serve the best po­ten­tial to live the lives they de­serve.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; 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.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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