No­vo Nordisk ad­dress­es off-la­bel Ozem­pic use as it grap­ples with mul­ti­ple short­ages

On the heels of We­govy sup­ply trou­bles, No­vo Nordisk is re­port­ing a short­age of its di­a­betes treat­ment Ozem­pic which con­tains the same ac­tive in­gre­di­ent, semaglu­tide.

The com­pa­ny told End­points News in an email last week that it’s ex­pe­ri­enc­ing “in­ter­mit­tent sup­ply dis­rup­tions” for the Ozem­pic pen that de­liv­ers 0.25 and 0.5 mg dos­es of the drug, caused by “in­cred­i­ble de­mand cou­pled with over­all glob­al sup­ply con­straints.” On Dec. 7, the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists re­port­ed short­ages af­fect­ing both the 0.25 mg or 5 mg dos­es, as well as the 1 mg and 2 mg dos­es us­ing var­i­ous pen in­jec­tors.

“The com­pa­ny is work­ing to re­solve the is­sue by ear­ly-2023,” the ASHP re­port stat­ed.

While No­vo Nordisk de­clined to con­firm whether the short­ages are due to off-la­bel use of Ozem­pic as a weight loss treat­ment, it did ac­knowl­edge that some providers may be pre­scrib­ing the drug for such use.

“While we rec­og­nize that some health­care providers may be pre­scrib­ing Ozem­pic for pa­tients whose goal is to lose weight, it is up to the clin­i­cal dis­cre­tion of each health­care provider to choose the best treat­ment ap­proach for their pa­tients,” the com­pa­ny said in an email.

Ozem­pic was ap­proved in 2017 for pa­tients with Type II di­a­betes, and won a la­bel ex­pan­sion back in 2020 to re­duce the risk of cer­tain heart prob­lems in Type II di­a­betes pa­tients. Its sib­ling drug, We­govy, al­so con­tains sem­ga­lu­tide at a high­er dose. We­govy was ap­proved last June as a once-week­ly in­jec­tion for chron­ic weight man­age­ment in adults, but quick­ly faced “un­prece­dent­ed de­mand” on top of man­u­fac­tur­ing is­sues.

No­vo halt­ed We­govy pro­mo­tions back in March as the com­pa­ny grap­pled with sup­ply is­sues, and promised on its Q3 call that all dose strengths would be avail­able by the end of the year. At the be­gin­ning of the month, ASHP list­ed all We­govy dose strengths as af­fect­ed by a cur­rent short­age.

While Bloomberg re­port­ed ear­li­er to­day that short­ages have led No­vo to de­lay We­govy’s launch in Eu­rope in­to next year, No­vo re­fut­ed those claims, adding that the launch is on track.

“We have com­mu­ni­cat­ed since our sec­ond-quar­ter and third-quar­ter fi­nan­cial re­ports that the first launch­es out­side of the US would hap­pen to­wards the end of 2022. We launched We­govy in Eu­rope (Den­mark) Mon­day, ac­cord­ing to plan,” the com­pa­ny said in an email.

Mean­while, Ozem­pic has tak­en Tik­Tok — and re­port­ed­ly Hol­ly­wood — by storm, with some #ozem­picweight­loss and re­lat­ed videos gath­er­ing hun­dreds of thou­sands of views. Aus­tralia’s reg­u­la­to­ry agency, the Ther­a­peu­tic Goods Ad­min­is­tra­tion, di­rect­ly linked an Ozem­pic short­age to off-la­bel use for weight loss ear­li­er this year.

“The world­wide short­age of semaglu­tide start­ed to af­fect Aus­tralia in ear­ly 2022 when No­vo Nordisk couldn’t sup­ply enough Ozem­pic to meet an un­ex­pect­ed in­crease in de­mand due to off-la­bel pre­scrib­ing for weight loss,” the agency said in a state­ment last month.

Ozem­pic raked in about $2.3 bil­lion last quar­ter, up 63% from last year, ac­cord­ing to No­vo’s Q3 re­sults.

“We did an­tic­i­pate that Ozem­pic would grow, just not at the pace that we are see­ing,” the com­pa­ny said in an email. “For pa­tients with Type 2 Di­a­betes, GLP-1 med­i­cines have be­come well-es­tab­lished treat­ments due in part to con­tin­ued in­no­va­tion with­in the class and in­creased uti­liza­tion.”

Fa­ti­ma Stan­ford, an obe­si­ty med­i­cine physi­cian sci­en­tist at Mass­a­chu­setts Gen­er­al Hos­pi­tal, said some of her pa­tients have strug­gled to fill pre­scrip­tions be­cause of GLP1 short­ages. How­ev­er, she added that off-la­bel use isn’t al­ways what you think.

“It’s im­por­tant to note that 80% of pa­tients with Type II di­a­betes al­so have obe­si­ty. So when we talk about us­ing it off-la­bel for weight reg­u­la­tion, we’re prob­a­bly treat­ing peo­ple that would have need­ed it any­way, for ei­ther weight and or blood sug­ar dys­reg­u­la­tion,” she said.

“No­vo Nordisk does not pro­mote, sug­gest, or en­cour­age off-la­bel use of our med­i­cines and is com­mit­ted to ful­ly com­ply­ing with all ap­plic­a­ble US laws and reg­u­la­tions in the pro­mo­tion of our prod­ucts,” No­vo said in an email. “We trust that health­care providers are eval­u­at­ing a pa­tient’s in­di­vid­ual needs and de­ter­min­ing which med­i­cine is right for that par­tic­u­lar pa­tient.”

Illustration: Assistant Editor Kathy Wong for Endpoints News

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