The Food and Drug Administration on Thursday approved Novo Nordisk’s diabetes pill Rybelsus as an initial treatment to lower blood sugar levels, a label expansion that will allow it to compete more directly with other oral drugs from Merck & Co. and Eli Lilly.
Rybelsus, which works like Novo’s Ozempic and Lilly’s Trulicity, gained FDA approval in 2019 as a daily oral alternative to those two drugs, which require weekly injections. However, that initial OK was accompanied by a recommendation doctors not prescribe Rybelsus as a first-line treatment for people with diabetes who are unable to control their blood sugar levels with diet and exercise alone. Merck’s Januvia and Lilly’s Jardiance, by comparison, already held approvals for that use.
