Wegovy woes continue as manufacturing issues will lead to further shortage of Novo’s obesity drug

As the new year rapid­ly ap­proach­es, and gyms and health food stores across Amer­i­ca pre­pare for a wave of peo­ple seek­ing weight loss, No­vo Nordisk has an­nounced that it does not ex­pect to meet de­mand for We­govy, its pre­scrip­tion in­jectable weight-loss med­ica­tion for obe­si­ty, un­til the sec­ond half of 2022 in the US.

The short­age comes due to man­u­fac­tur­ing is­sues at a con­tract man­u­fac­tur­er that was tasked with fill­ing sy­ringes for the pens. The news comes just days af­ter No­vo an­nounced that it would in­vest rough­ly $2.58 bil­lion to ex­pand its man­u­fac­tur­ing hub in Kalund­borg, Den­mark with three new fa­cil­i­ties and the ex­pan­sion of a fourth to keep up with the suc­cess of its di­a­betes and obe­si­ty med semaglu­tide, We­govy and Ry­bel­sus.

‘We were mak­ing progress and had pro­ject­ed to sta­bi­lize sup­ply in ear­ly 2022,’ the com­pa­ny said in a state­ment. ‘How­ev­er, we have been in­formed that our con­tract man­u­fac­tur­er re­spon­si­ble for fill­ing the We­govy pens for the US mar­ket has tem­porar­i­ly stopped de­liv­er­ies and man­u­fac­tur­ing fol­low­ing is­sues re­lat­ed to good man­u­fac­tur­ing prac­tices.’

This is not No­vo’s first time deal­ing with a short­age of the drug in its young life. Sup­ply sold out in June, soon af­ter the FDA is­sued an ap­proval for the drug and it launched. There’s al­ready a one-month de­lay that led to No­vo apol­o­giz­ing to cus­tomers for its in­abil­i­ty to meet with an ‘un­prece­dent­ed de­mand.’

No­vo al­so spon­sored a mar­ket­ing cam­paign fea­tur­ing ac­tress Queen Lat­i­fah at the helm to change the nar­ra­tive around obe­si­ty, look­ing to frame the di­ag­no­sis as a man­age­able health con­di­tion in­stead of a char­ac­ter flaw.

Over 40% of Amer­i­ca’s adult pop­u­la­tion, around 100 mil­lion peo­ple, are clas­si­fied as obese. Less than 10% of that pop­u­la­tion takes an an­ti-obe­si­ty med­ica­tion. We­govy is the same med­ica­tion as No­vo’s type 2 di­a­betes drug Ozem­pic, but at a high­er dose.

‘We are do­ing our ut­most to over­come sup­ply con­straints, but un­for­tu­nate­ly this will take time to re­solve,’ the com­pa­ny said.

The chal­lenges fac­ing sup­ply are not go­ing to im­pact the 2021 fi­nan­cial out­look that has al­ready been re­port­ed, No­vo said in a state­ment.

Obe­si­ty drugs have his­tor­i­cal­ly strug­gled fol­low­ing FDA ap­proval. No­vo’s Sax­en­da, launched in 2015, re­quires dai­ly in­jec­tions, and on­ly 100,000 pa­tients were pre­scribed the drug. Cur­rax’s Con­trave failed to gain trac­tion, though it is still in play long-term, and Vivus filed for bank­rupt­cy less than 10 years af­ter its weight loss drug Qsymia failed to gen­er­ate even $9 mil­lion in sales in Q1 2020.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

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Sen. Joe Manchin (D-WV) at the Capitol on Friday, Dec. 17 (J. Scott Applewhite/AP Images)

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Brian Culley, Lineage Cell Therapeutics CEO

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The AbbVie/Alvotech debacle on a Humira biosimilar has taken yet another turn — escalating tensions between the two biotechs.

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Tom Plitz (L) and Arthur Roach, Chord Therapeutics CEO and founder

About a year after Geneva-based Chord Therapeutics emerged from stealth to see if it could repurpose an old chemotherapy agent for rare diseases, Merck KGaA is swooping in with a buyout.

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