Af­ter Ab­b­Vie’s Rin­voq first got ap­proved back in 2019, JAK in­hibitors have been cloud­ed by nu­mer­ous safe­ty is­sues and events, like with ri­val Pfiz­er’s Xel­janz. Now with the newest study out of Ab­b­Vie, there might be room to fol­low the route its sales king Hu­mi­ra did — ex­pand­ing the drug in­to oth­er in­di­ca­tions and calm­ing con­cerns about the drug class.

Ab­b­Vie an­nounced top-line re­sults ear­li­er this week from a Phase III study for upadac­i­tinib, its JAK in­hibitor that had been pre­vi­ous­ly ap­proved for rheuma­toid arthri­tis. The study, called U-EN­DURE, was a 52-week main­te­nance study in adults with mod­er­ate to se­vere Crohn’s dis­ease “who had an in­ad­e­quate re­sponse or were in­tol­er­ant to a con­ven­tion­al or bi­o­log­ic ther­a­py.” Rin­voq met the co-pri­ma­ry end­points of en­do­scop­ic re­sponse and clin­i­cal re­mis­sion, as well as the sec­ondary end­point of en­do­scop­ic re­mis­sion.

The study en­rolled pa­tients from two pre­vi­ous Phase III tri­als — U-EX­CEED and U-EX­CEL, which com­pared pa­tients to place­bo at 12 weeks — and gave them a small­er dose for a longer pe­ri­od of time. Both of those stud­ies met the same co-pri­ma­ry end­points as the ones in U-EN­DURE.

Ac­cord­ing to Ab­b­Vie, pa­tients in pre­vi­ous stud­ies were giv­en the JAK in­hibitor at a 45mg dose. For this one, pa­tients were ran­dom­ized to ei­ther re­ceive a 30mg dose (168 pa­tients), a 15mg dose (169 pa­tients) or place­bo (165 pa­tients).

Ab­b­Vie re­port­ed its num­bers at a p-val­ue of p<0.0001:

• Clin­i­cal re­mis­sion ac­cord­ing to the Crohn’s Dis­ease Ac­tiv­i­ty In­dex: 37% at 15mg, 48% at 30 mg, 15% at place­bo.
• Clin­i­cal re­mis­sion as mea­sured by stool fre­quen­cy and ab­dom­i­nal pain score (SF/AP): 36% at 15mg, 46% at 30 mg, 14% at place­bo.
• En­do­scop­ic re­sponse: 28% at 15mg, 40% at 30 mg, 7% at place­bo.
• En­do­scop­ic re­mis­sion: 19% at 15mg, 29% at 30 mg, 5% at place­bo.

In the case of this study, in par­tic­u­lar, no new safe­ty risks were iden­ti­fied.

Rin­voq is Ab­b­Vie’s at­tempt at re­peat­ing the vast­ly ex­pand­ed fran­chise of Hu­mi­ra, some­thing that CEO Rick Gon­za­lez not­ed on the phar­ma’s an­nu­al earn­ings call back in Feb­ru­ary when he said that Rin­voq plus Skyrizi “will be com­mer­cial­ized across all of Hu­mi­ra’s ma­jor in­di­ca­tions — plus atopic der­mati­tis.” He fur­ther not­ed at the time that Ab­b­Vie ex­pects com­bined peak sales for both drugs “to ex­ceed the peak rev­enues achieved by Hu­mi­ra.”

“These re­sults are en­cour­ag­ing and would be par­tic­u­lar­ly im­por­tant for pa­tients who have not found re­lief with oth­er con­ven­tion­al or bi­o­log­ic treat­ment op­tions,” said lead study in­ves­ti­ga­tor Ju­lian Panés, who is the head of the IBD Unit at Hos­pi­tal Clínic de Barcelona.

Ab­b­Vie fur­ther said that full re­sults from the U-EN­DURE study main­te­nance pe­ri­od will be pre­sent­ed at up­com­ing med­ical con­fer­ences, and pub­lished in a peer-re­viewed med­ical jour­nal — time to be de­ter­mined. Ad­di­tion­al­ly, da­ta from the study will be used in fu­ture reg­u­la­to­ry sub­mis­sions.

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”