© Reuters. A handout picture exhibits 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 house 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 shed weight.
Ozempic incorporates semaglutide, an ingredient in Novo’s massively common anti-obesity drug Wegovy. Ozempic will not be formally authorised to deal with weight problems, however that hasn’t held again demand.
According to a word to healthcare professionals from Novo and the European Medicines Agency (EMA), the Danish drugmaker will “temporarily reduce the supply of Victoza” with a purpose 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 accordance with the assertion on the EMA’s web site.
The scarcity of each would “deteriorate” through the the rest of this 12 months, Novo warned.
Both 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 medical doctors within the doc.
It would 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 technique that Novo has already used within the United States to handle demand for Wegovy that has far exceeded provides.
In a bid to handle uncomfortable side effects and get the physique used to the gut-hormone medicine, 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 referred to as 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 medical doctors to contemplate different injectable GLP-1 medicine or “other suitable alternatives” the place Ozempic or Victoza usually are not accessible for sufferers.
In an indication of Europe’s scramble for Ozempic, Germany’s medicine regulator is contemplating banning Ozempic exports, a transfer that a number of fellow EU members similar to France and Austria have already imposed.
Several international locations 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 completed little to mood the clamour in Europe for Ozempic, as volumes of Wegovy have been restricted resulting from manufacturing bottlenecks.
Novo, which has earmarked $6 billion to spice up manufacturing in Denmark, mentioned earlier this month the trade was removed from with the ability to produce sufficient weight-loss medicine 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 medicine regulator has really useful approval however the EU Commission’s last phrase remains to be pending.