J&J boasts im­proved car­dio safe­ty with SGLT2 fran­chise drug In­vokana

David Matthews, Steer­ing Com­mit­tee Co-Chair

J&J scored vi­tal­ly im­por­tant car­dio safe­ty da­ta for its SGLT2 di­a­betes drug In­vokana in a large Phase III out­comes study, which it hap­pi­ly shared with re­searchers at the an­nu­al Amer­i­can Di­a­betes As­so­ci­a­tion con­fer­ence in San Diego on Mon­day af­ter­noon.

The phar­ma gi­ant $JNJ spelled out a slate of pos­i­tive risk re­duc­tions on three key mea­sures, with a 14% re­duc­tion in risk for a com­pos­ite score on CV mor­tal­i­ty as well as non­fa­tal my­ocar­dial in­farc­tion and stroke, with each mea­sure con­tribut­ing to the pos­i­tive score.

In­ves­ti­ga­tors and pay­ers can now pour over the re­sults and start do­ing their com­par­isons with Jar­diance, the ri­val SGLT2 drug from Eli Lil­ly $LLY and Boehringer In­gel­heim which orig­i­nal­ly got this ball rolling two years ago. The big ques­tion now is whether this is a class ef­fect that will even­tu­al­ly ben­e­fit all play­ers, or pro­vide enough da­ta to start to sin­gle out one or two as bet­ter than the rest.

Class ef­fect may be the fa­vorite to­day, as J&J’s com­pos­ite 14% re­duc­tion in risk matched Lil­ly’s over­all num­ber per­fect­ly. Spe­cial­ists, though, will note that not all the end­points matched up, mak­ing cross tri­al com­par­isons tricky.

On the oth­er hand Jar­diance was more ef­fec­tive in cut­ting the risk of death (-38%) com­pared to a much more mod­est 13% re­duc­tion for In­vokana, which achieved more bal­anced ef­fects spread among end­points. And In­vokana was linked to a sig­nif­i­cant­ly high­er risk of am­pu­ta­tions, a safe­ty con­cern that has al­ready trig­gered a black box warn­ing.

Ad­di­tion­al analy­sis al­so demon­strat­ed that In­vokana (canagliflozin) low­ered the risk of HHF by 33% (HR: 0.67; 95% CI: 0.52 to 0.87) and pro­vid­ed sus­tained pos­i­tive ef­fects on glycemic and blood pres­sure con­trol, as well as weight re­duc­tion, with “wide-rang­ing dura­bil­i­ty,” J&J said in its state­ment. In ad­di­tion, the phar­ma gi­ant not­ed, their drug de­layed pro­gres­sion of al­bu­min­uria and re­duc­ing the risk of clin­i­cal­ly im­por­tant re­nal com­pos­ite out­comes (such as re­nal death, re­nal re­place­ment ther­a­py, and 40% re­duc­tion of eGFR) by 40%.

Mer­ck $MRK and Pfiz­er $PFE on­ly re­cent­ly out­lined their pos­i­tive Phase III da­ta for er­tugliflozin, look­ing for an ap­proval that will put them up against In­vokana, Jar­diance as well as As­traZeneca’s Farx­i­ga. Their car­dio out­comes da­ta, though, isn’t ex­pect­ed un­til 2019, giv­ing the lead­ers plen­ty of time to get fur­ther es­tab­lished first.

“Pa­tients with di­a­betes are two to four times more like­ly to suf­fer from as­so­ci­at­ed co­mor­bidi­ties, such as heart fail­ure and kid­ney dis­ease, and the CAN­VAS re­sults demon­strate the po­ten­tial of canagliflozin in re­duc­ing the risk for such con­di­tions in high-risk type 2 di­a­betes pa­tients,” said David Matthews, the tri­al’s steer­ing com­mit­tee co-chair and a pro­fes­sor of di­a­bet­ic med­i­cine at the Uni­ver­si­ty of Ox­ford. “These da­ta are promis­ing as they sug­gest canagliflozin may of­fer po­ten­tial ben­e­fits for pa­tients with type 2 di­a­betes, who are al­so fac­ing com­pli­ca­tions from, or are at risk for, hos­pi­tal­iza­tion for heart fail­ure or kid­ney dis­ease.”


Im­age: Shut­ter­stock

John Hood [file photo]

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