logo
Plus   Neg
Share
Email

Alnylam Gains Approval For OXLUMO In European Union For Treatment Of Primary Hyperoxaluria Type 1

Alnylam Pharmaceuticals, Inc. (ALNY) said the European Commission has granted marketing authorization for OXLUMO (lumasiran), an RNAi therapeutic, for the treatment of primary hyperoxaluria type 1 in all age groups. The approval is based on efficacy and safety findings from both the ILLUMINATE-A and ILLUMINATE-B Phase 3 studies of lumasiran.

Alnylam Pharma noted that the company has filed a New Drug Application with the U.S. FDA. The FDA has granted a Priority Review for the NDA and has set an action date of December 3, 2020.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
House-Autry Mills, Inc. issued a recall for its 9 ounce bottles of House-Autry Tartar Sauce due to the co-manufacturer's verification of spoilage associated with the product, according to a statement published by the U.S. Food and Drug Administration or FDA. The North Carolina-based company said the product may be unsuitable for consumption. Kimberly-Clark Corp. (KMB) on Monday reported a profit for the fourth quarter that edged down from last year, hurt by higher expenses, despite 6 percent sales growth. Both adjusted earnings per share and net sales topped analysts' expectations. The company also initiated adjusted earnings and net sales growth guidance for the full-year 2021. Shares of Philips Electronics NV were gaining around 3 percent in Amsterdam trading after the Dutch consumer electronics giant reported Monday higher results in its fourth quarter. The company also proposed dividend, and said it sees growth in fiscal 2021 comparable sales and adjusted margin.
Follow RTT