Adalvo has submitted its DCP filing for Teduglutide on Day-1 following the expiry of Data Exclusivity.
Teduglutide has been developed for the treatment of short bowel syndrome (SBS), a rare condition that impairs the small intestine’s ability to properly absorb nutrients and fluids.
This submission presents a first-to-market opportunity for Adalvo, underscoring our commitment to addressing unmet medical needs in the rare disease segment. With no alternative pharmaceutical treatments currently available for SBS, the wider availability of Teduglutide is highly anticipated. This strategic filing reflects Adalvo’s focus on providing high-value, differentiated products to the market in a timely and efficient manner.
Alongside the EU DCP filing, Adalvo has also submitted for regulatory approval in Russia.
In 2023, Teduglutide achieved global sales of approximately $184 million, according to IQVIA.
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