© Reuters. A handout picture reveals a nine-month provide of Novo Nordisk’s diabetes drug Ozempic which was bought by a person from on-line pharmacies within the UK for “off-label” use for weight reduction and saved in his fridge at dwelling in London, Britain, October
By Ludwig Burger and Eva Mathews
(Reuters) – Novo Nordisk (NYSE:) will ration starter kits of Ozempic in Europe and cut back provides of one other diabetes drug, Victoza, to prioritise producing Ozempic, which has seen a surge in demand from folks utilizing it to drop pounds.
Ozempic accommodates semaglutide, an ingredient in Novo’s massively in style anti-obesity drug Wegovy. Ozempic shouldn’t be formally accredited to deal with weight problems, however that hasn’t held again demand.
Based on a word to healthcare professionals from Novo and the European Medicines Company (EMA), the Danish drugmaker will “temporarily reduce the supply of Victoza” so as to improve the provision of Ozempic.
Intermittent Ozempic shortages are anticipated all through 2024, whereas Victoza shortages are anticipated at the least till the second quarter of 2024, in line with the assertion on the EMA’s web site.
The scarcity of each would “deteriorate” through the the rest of this yr, Novo warned.
Each Victoza and Ozempic are injections based mostly on the substance class of GLP-1 receptor agonists, however solely the latter has been related to appreciable weight reduction and suppression of urge for food, along with regulating insulin manufacturing.
The lively ingredient in Victoza is named liraglutide.
“No new patients should be started on Victoza until at least Q2 2024 when supply is expected to normalise,” Novo urged docs within the doc.
It will additionally restrict the provision of the 0.25-mg beginning dose of Ozempic to prioritise sufferers already on the weekly remedy over potential new sufferers, a method that Novo has already utilized in america to handle demand for Wegovy that has far exceeded provides.
In a bid to handle unwanted side effects and get the physique used to the gut-hormone medication, each Ozempic and Wegovy are initially given at low starter doses and the focus of lively ingredient per injection is elevated over months in a follow often called dose escalation.
“It is recommended to limit initiations of new patients (on Ozempic) during the shortage and until the supply situation improves which is expected in Q1 2024,” Novo mentioned.
It additionally informed docs to think about different injectable GLP-1 medication or “other suitable alternatives” the place Ozempic or Victoza will not be obtainable for sufferers.
In an indication of Europe’s scramble for Ozempic, Germany’s medication regulator is contemplating banning Ozempic exports, a transfer that a number of fellow EU members resembling France and Austria have already imposed.
A number of nations together with Britain, Belgium and Germany have quickly banned or strongly discouraged its use for weight reduction to safe availability for diabetics however enforcement has confirmed troublesome.
Novo’s launch of Wegovy in Britain, Germany, Norway and Denmark, has to this point finished little to mood the clamour in Europe for Ozempic, as volumes of Wegovy have been restricted because of manufacturing bottlenecks.
Novo, which has earmarked $6 billion to spice up manufacturing in Denmark, mentioned earlier this month the business was removed from having the ability to produce sufficient weight-loss medication to fulfill world demand.
Eli Lilly (NYSE:)’s drug tirzepatide, also called Mounjaro, has proven even better weight-loss potential in trials than Wegovy, however the medium-term provide outlook for that drug in Europe is as but unsure.
The EU medication regulator has beneficial approval however the EU Fee’s last phrase continues to be pending.
