(Reuters) – Spanish pharma company Almirall said on Tuesday it expects the launch of psoriasis treatment drug, Tildrakizumab, in Europe to get delayed by at least six months due to regulatory hurdles.
The company said the anticipated launch of the drug was moved to the end of 2018 or early 2019 from mid-2018.
“This follows a communication received from European Medicines Agency (EMA), which is extending the scope of the clinical sites under review,” the company said in a statement.
Almirall entered into licensing agreement for development and commercialization of the drug in Europe with India’s Sun Pharma in July 2016. The companies filed for the regulatory approval in March 2017.
Reporting by Nadiia Karpina in Gdynia, editing by Louise Heavens