No­vo Nordisk launch­es obe­si­ty treat­ment We­govy in Japan

No­vo Nordisk’s Japan­ese sub­sidiary has launched the obe­si­ty treat­ment We­govy (semaglu­tide) in Japan, though it plans to take a cau­tious ap­proach, “pro­ceed­ing in stages to pen­e­trate the mar­ket” said Mariko Shimizu, head of the obe­si­ty busi­ness di­vi­sion at No­vo Nordisk Phar­ma, the com­pa­ny’s Japan­ese sub­sidiary.

We­govy’s ac­tive in­gre­di­ent is semaglu­tide, the same GLP-1 re­cep­tor ag­o­nist as Ozem­pic, which was launched in the US in 2017 as a type 2 di­a­betes treat­ment. Due to the dif­fi­cul­ties in man­u­fac­tur­ing the in­jectable drug, it was placed on the FDA’s drug short­age list in March 2023, where it re­mains to this day.

The pa­tient cri­te­ria for We­govy in Japan dif­fer slight­ly from oth­er coun­tries due to Japan’s de­f­i­n­i­tion of obe­si­ty, which is set at a low­er thresh­old than in the US. Use of the drug is lim­it­ed to obe­si­ty cas­es that have ei­ther hy­per­ten­sion, dys­lipi­demia, or type 2 di­a­betes and where suf­fi­cient ef­fects can­not be ob­tained from di­et ther­a­py and ex­er­cise. Pa­tients are el­i­gi­ble who have a BMI of 27 kg/m2 or high­er with at least two obe­si­ty-re­lat­ed health is­sues, or who have a BMI of 35 kg/m2 or high­er.

Ac­cord­ing to the Guide­lines for the Man­age­ment of Obe­si­ty Dis­ease 2022 by the Japan So­ci­ety for the Study of Obe­si­ty, obe­si­ty is di­ag­nosed when the BMI is 25 kg/m2 or high­er, and if there are 11 health com­pli­ca­tions nec­es­sary for di­ag­nos­ing obe­si­ty. Thus, not every­one with obe­si­ty au­to­mat­i­cal­ly qual­i­fies for treat­ment.

Re­gard­ing its mech­a­nism of ac­tion, Hi­roshi Sugii, ex­ec­u­tive vice pres­i­dent and head of the de­vel­op­ment di­vi­sion, said that “since the re­cep­tor is ex­pressed through­out the body, GLP-1 has a wide va­ri­ety of ef­fects. Its mech­a­nism is to act on the hy­po­thal­a­mus in the brain, low­er­ing the feel­ing of hunger, in­creas­ing the feel­ing of full­ness, and sup­press­ing ap­petite. How­ev­er, since it is an in­cretin hor­mone, it al­so has the ef­fect of sup­press­ing gas­tric motil­i­ty, and these fac­tors work to­geth­er.”

One of the rea­sons why it is tak­ing so long to pen­e­trate the mar­ket is that sup­ply-side is­sues still re­main. No­vo has had lim­it­ed ship­ments of Ozem­pic in Japan since Au­gust 2023, and has re­quest­ed that med­ical in­sti­tu­tions re­frain from pre­scrib­ing new drugs to pa­tients with type 2 di­a­betes.

“What we pri­or­i­tize is en­sur­ing the con­tin­u­a­tion of treat­ment. To this end, we have been in­ves­ti­gat­ing the pro­duc­tion sta­tus of raw drugs and putting in place a sys­tem to con­tin­ue sup­ply. We have plans to ex­pand the pro­duc­tion of raw drugs over the next five years,” said Kasper Bød­ker Mejl­vang, pres­i­dent and rep­re­sen­ta­tive di­rec­tor of No­vo Nordisk Phar­ma.

Up­on the ap­proval of We­govy, the Min­istry of Health, Labour and Wel­fare, in col­lab­o­ra­tion with aca­d­e­m­ic so­ci­eties, cre­at­ed a “Guide­line for Pro­mot­ing Op­ti­mal Use.” This in­clud­ed con­sid­er­a­tions such as the re­quire­ment for an in­sti­tu­tion to be of­fi­cial­ly rec­og­nized as an ed­u­ca­tion­al train­ing fa­cil­i­ty by the aca­d­e­m­ic so­ci­ety, and that the treat­ment was in­tend­ed for pa­tients who haven’t seen sig­nif­i­cant im­prove­ments de­spite con­duct­ing ap­pro­pri­ate di­etary and ex­er­cise reg­i­mens for more than six months. Giv­en these con­sid­er­a­tions, the com­pa­ny does not pre­dict a sud­den surge in de­mand with­in Japan.

In or­der to ad­dress this, No­vo has been im­ple­ment­ing the fol­low­ing mea­sures: (1) mon­i­tor­ing on­line and oth­er plat­forms for ad­ver­tise­ments of off-la­bel pre­scrip­tions and pro­vid­ing in­for­ma­tion to reg­u­la­to­ry au­thor­i­ties if any are found; (2) send­ing Med­ical Rep­re­sen­ta­tives di­rect­ly to med­ical in­sti­tu­tions that pre­scribe off-la­bel to de­mand com­pli­ance with prop­er use; (3) and re­frain­ing from pro­mo­tion­al ac­tiv­i­ties to med­ical in­sti­tu­tions that con­tin­ue off-la­bel use.

In clin­i­cal tri­als, it has al­so been re­port­ed that long-term ad­min­is­tra­tion re­duced the risk of death from car­dio­vas­cu­lar dis­eases such as my­ocar­dial in­farc­tion and stroke.

“Re­duc­ing ex­cess weight al­so has ben­e­fits for the health care sys­tem in that it can pre­vent var­i­ous obe­si­ty-re­lat­ed com­pli­ca­tions. Pre­vent­ing obe­si­ty-re­lat­ed dis­eases at an ear­ly stage can al­so re­duce the bur­den of med­ical costs. This will help en­sure la­bor pro­duc­tiv­i­ty. In ad­di­tion, it will al­so re­duce the bur­den on med­ical work­ers,” Mejl­vang said.