ARQT - Canada accepts Arcutis Biotherapeutics' new drug submission for its psoriasis skin cream
- Arcutis Biotherapeutics' ( NASDAQ: ARQT ) Canadian unit on Monday said the country's drug regulator had accepted its new drug submission (NDS) for its plaque psoriasis skin cream.
- Health Canada accepted Arcutis Canada's NDS for roflumilast cream 0.3% for the treatment of plaque psoriasis in adults and adolescents.
- Arcutis Canada said that the safety and efficacy of roflumilast cream was still under investigation, and that market authorization in Canada had not been granted yet.
- The NDS was supported by efficacy data from the company's phase 3 trials, along with results from long-term safety studies.
- Plaque psoriasis is the most common form of psoriasis, which is a chronic inflammation of the skin.
- ARQT stock +1.6% to $25.90 in morning trading.
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Canada accepts Arcutis Biotherapeutics' new drug submission for its psoriasis skin cream