German Regulatory Authority Considers Export Restrictions for Ozempic Due to European Supply Shortages

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A packet of Ozempic, a semaglutide injection for treating type 2 diabetes and manufactured by Novo Nordisk, is visible at a Provo, Utah pharmacy. REUTERS/George Frey REFILE – CORRECTING MONTH/File Photo

The head of the BfArM informs Spiegel that he is seeking the advice of lawmakers regarding EU market rules and the high obstacles in place.

Several EU countries have already restricted the export of Ozempic, and it remains uncertain when Lilly’s new drug will address the demand for weight loss.

German regulator BfArM is contemplating halting Ozempic exports due to the shortage of the highly sought-after diabetes medication across Europe, which is attributed to its weight-loss benefits.

Novo Nordisk’s Ozempic has resulted in supply shortages in Europe, and some countries have temporarily banned its off-label use for weight loss to ensure its availability for diabetics.

The launch of Novo’s anti-obesity drug Wegovy, a high-dose version of Ozempic, in select European countries has so far not alleviated the demand for Ozempic, largely due to limited volumes of Wegovy as a result of production issues.

While Ozempic is officially approved to treat type 2 diabetes, it is increasingly being prescribed off-label for weight loss due to having the same active ingredient as the scarce Wegovy.

BfArM President Karl Broich told Spiegel magazine, “We are currently in talks with lawmakers about what we will do if the current measures and the public messages don’t show an effect. We would then think about imposing an export ban so that enough remains in the country for the patients that need it,”

Novo, which has allocated $6 billion to enhance production in Denmark, stated last week that the industry is far from meeting the global demand for weight-loss drugs.

Eli Lilly’s tirzepatide, also known as Mounjaro, has shown promising weight-loss potential, and was recently cleared for wider use against obesity in the United States and Britain.

Some ledigimtate supplied are being remarked in poland and romania

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