BioCentury
ARTICLE | Regulation

June 4 Quick Takes: FDA approves Novo’s semaglutide for chronic weight management; plus Liminal, Regeneron, Rigel, Myra and more

June 5, 2021 2:18 AM UTC

In FDA’s first approval of a new therapy for chronic weight management since 2014, the agency approved GLP-1 analog Wegovy semaglutide from Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO). The drug is indicated for patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment, or in patients with a BMI of 30 kg/m2 or greater.

Liminal BioSciences Inc. (NASDAQ:LMNL) will receive a rare pediatric disease priority review voucher now that FDA has approved Ryplazim plasminogen, human-tvmh to treat plasminogen deficiency type 1, or hypoplasminogenia. The approval, based on results from 15 patients in a Phase II/III trial, is the first for Liminal and its Prometic Biotherapeutics Inc. subsidiary. Kedrion S.p.A. holds an option to acquire Liminal’s plasma therapeutics business, including Ryplazim; Liminal would be entitled to up to 70% of the proceeds from the subsequent sale of the voucher...

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