Skyrizi, a key drug in Ab­b­Vie’s post-Hu­mi­ra fu­ture, has added an­oth­er feath­er to its cap.

On Tues­day, the IL-23 in­hibitor emerged su­pe­ri­or in a head-to-head 327-pa­tient tri­al against No­var­tis’ dom­i­nant Cosen­tyx in pa­tients with mod­er­ate-to-se­vere plaque pso­ri­a­sis.

Da­ta showed Skyrizi in­duced sig­nif­i­cant­ly high­er rates of skin clear­ance com­pared to Cosen­tyx, meet­ing the pri­ma­ry goal of su­pe­ri­or­i­ty with at least a 90% im­prove­ment from base­line in the Pso­ri­a­sis Area and Sever­i­ty In­dex (PASI 90) at week 52. Over­all, 87% of Skyrizi-treat­ed pa­tients hit PASI 90, ver­sus 57% of Cosen­tyx-treat­ed pa­tients at the one year mark.

The oth­er main goal of non-in­fe­ri­or­i­ty at week 16 — 74% of Skyrizi pa­tients achieved PASI 90 com­pared to 66% of Cosen­tyx pa­tients — was al­so met. Skyrizi al­so eclipsed Cosen­tyx on all sec­ondary end­points, in­clud­ing PASI 100, and PASI 75.

In the fall of 2017, Skyrizi was eval­u­at­ed against J&J’s Ste­lara and its own Hu­mi­ra in a pso­ri­a­sis study — and emerged vic­to­ri­ous, hand­some­ly out­pac­ing the ri­val drugs in clear­ing pso­ri­a­sis.

These head-to-head stud­ies are key to es­tab­lish­ing Skyrizi’s po­si­tion in a crowd­ed mar­ket, which in­cludes Hu­mi­ra, No­var­tis’ an­ti-IL17 Cosen­tyx, J&J’s an­ti-IL23 Trem­fya, an­ti-IL12/23 Ste­lara, as well as Lil­ly’s an­ti-IL17 Taltz.

Skyrizi is not the first pure IL-23 in­hibitor to be ap­proved — Trem­fya was ap­proved in 2017 and Ilumya in 2018. But the Ab­b­Vie drug has a dos­ing ad­van­tage over Trem­fya — it is ad­min­is­tered every 12 weeks, ver­sus once every two months for Trem­fya, SVB Leerink’s Ge­of­frey Porges said on Wednes­day, not­ing that oth­er pso­ri­a­sis bi­o­log­ics in ad­di­tion to the oral Ote­zla gen­er­at­ed a com­bined $11.1 bil­lion in 2018 sales.

“This does not in­clude sales of an­ti-TN­Fs in pso­ri­a­sis, which should de­crease as pa­tients move to these new, more ef­fi­ca­cious ther­a­pies. These prod­ucts al­so all achieved $500 mil­lion – $1 bil­lion in the sec­ond year of launch, which is like­ly to al­so be achieved by Skyrizi,” SVB Leerink’s Ge­of­frey Porges wrote in a note last year.

“Over­all bi­o­log­ics are still used in on­ly 30% of the mod­er­ate to se­vere pso­ri­a­sis pop­u­la­tion, (per JNJ in 2017), and Ab­b­Vie’s Skyrizi should ben­e­fit from both best-in-cat­e­go­ry ef­fi­ca­cy (i.e. mar­ket share gains) and the con­tin­ued rapid mar­ket ex­pan­sion.”

Skyrizi was ap­proved in April 2019. Ab­b­Vie paid Boehringer In­gel­heim $595 mil­lion up­front to li­cense rights to the drug, known chem­i­cal­ly as risankizum­ab, in ear­ly 2016. Eval­u­ate has pegged Skyrizi as the num­ber 3 block­buster on its list of heavy­weight drugs launched in 2019, es­ti­mat­ing the drug could earn more than $2 bil­lion in 2024 — a far cry from Ab­b­Vie’s home­grown es­ti­mate of $4 bil­lion to $5 bil­lion in peak sales. Porges has fore­cast ad­just­ed peak an­nu­al sales of $3 bil­lion.

Last Au­gust, Lil­ly’s Taltz beat J&J’s Trem­fya in a head-to-head pso­ri­a­sis study. In 2018, J&J ran its own head-to-head pso­ri­a­sis tri­al against Cosen­tyx — and came out with da­ta that showed Trem­fya su­per­seded No­var­tis’ dom­i­nant ri­val.

So­cial im­age: Ab­b­Vie

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.