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UK's MHRA allows early access to lumasiran for ultra-rare disease pharmatimes
July 16, 2020
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Alnylam's lumasiran a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).
Alnylam presents positive phase 3 results from ILLUMINATE-A study of Lumasiran pharmaceutical-business-review
June 10, 2020
Alnylam Pharmaceuticals announced positive Phase 3 results from the ILLUMINATE-A study of lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) ...
Alynlam completes EU, US filings for lumasiran pharmatimes
April 10, 2020
Alnylam has completed the submission of marketing applications for lumasiran on both sides of the Atlantic for the ultra-rare inherited disease primary hyperoxaluria type 1 (PH1).
Alnylam seeks FDA approval for lumasiran in primary hyperoxaluria type 1 pharmaceutical-business-review
April 10, 2020
Alnylam Pharmaceuticals has filed an application with the US Food and Drug Administration (FDA) seeking the latter’s approval for lumasiran for the treatment of primary hyperoxaluria type 1 (PH1).
Alnylam initiates rolling submission of NDA for Lumasiran in primary Hyperoxaluria Type 1 pharmaceutical-business-review
January 15, 2020
Alnylam Pharmaceuticals has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperox
Lumasiran drug achieves primary and secondary endpoints in Phase III study europeanpharmaceuticalreview
December 23, 2019
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.