US FDA extends review period for expanded use of Abbvie’s psoriasis drug
The US Food and Drug Administration (FDA) was reviewing the application for the use of Skyrizi in patients aged 16 years or older with moderate-to-severe Crohn's disease, a type of inflammatory bowel disease
Abbvie Inc said recently the US health agency extended the review period for the expanded use of its newer psoriasis drug Skyrizi by three months, citing the need for more time to review additional data submitted by the company.
The US Food and Drug Administration (FDA) was reviewing the application for the use of Skyrizi in patients aged 16 years or older with moderate-to-severe Crohn’s disease, a type of inflammatory bowel disease.
Skyrizi, which was approved in the US in 2019 to treat moderate-to-severe plaque psoriasis in adults, brought in $895 million in sales during company’s last reported quarter.
Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and commercialisation of the drug.
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