The head of German drug regulator BfArM is considering an export ban on Novo Nordisk's (NOVOb.CO) diabetes drug Ozempic, which is in high demand for its weight-loss benefits, to prevent a worsened supply shortage.
Ozempic is approved to treat type 2 diabetes but has increasingly been prescribed "off-label" to treat weight loss because it has the same active ingredient as Novo's hugely popular but scarce anti-obesity drug Wegovy.
"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," BfArM President Karl Broich told Spiegel magazine.
"We would then think about imposing an export ban so that enough remains in the country for the patients that need it," said Broich, adding that the drug was going to other European countries and the United States.
He said some Ozempic was being moved out of the country because it is cheaper there than elsewhere, and demand was driven by use for weight loss.
Broich cautioned that export restrictions can only be rarely used and legal hurdles were high because of the European Union's single market.
In a statement on its website, BfArM reiterated a call for physicians to only prescribe drugs from the class of GLP-1 receptor agonists, which include Ozempic and Eli Lilly's (LLY.N) Trulicity, for their approved use against diabetes.
It added that availability of the drugs had been limited since the spring of this year despite efforts by drugmakers to ramp up production. It also urged "all relevant actors" not to export the drugs.
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