Posted by Michael Wonder on 10 Jan 2020
Alnylam initiates rolling submission of new drug application to U.S. FDA for lumasiran for the treatment of primary hyperoxaluria type 1
10 January 2020 - Company plans to complete submission in early 2020.
Alnylam Pharmaceuticals announced today that the Company has initiated a rolling submission of its new drug application to the U.S. FDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1 (PH1).
Lumasiran has also received both U.S. and EU orphan drug designations, a breakthrough therapy designation from the FDA and a Priority Medicines (PRIME) designation from the EMA. Alnylam intends to file a marketing authorisation application with the EMA in early 2020.
