Ascendis Pharma's TransCon CNP Gets EU Orphan-Drug Designation Recommendation for Achondroplasia

MT Newswires Live11-06

Ascendis Pharma (ASND) said Friday that the European Medicines Agency's Committee for Orphan Medicinal Products recommended maintaining orphan medicinal product designation for once-weekly TransCon CNP for the treatment of achondroplasia in children.

If TransCon CNP receives marketing authorization in the European Union, the orphan designation would provide 10 years of market exclusivity, the biopharmaceutical company said.

The European Commission's final decision on Ascendis' marketing authorization application is expected in the fourth quarter.

The recommendation follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use on marketing authorization for once-weekly TransCon CNP to treat children aged 2 years and older with achondroplasia whose epiphyses are not closed.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment