Novo Nordisk reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) for the once-daily Rybelsus (semaglutide) tablets in 7 mg or 14 mg for the treatment of adults with type 2 diabetes.
Rybelsus, which is taken along with diet and exercise to improve blood sugar (glucose) in type 2 diabetes patients, is the first and only glucagon-like peptide-1 (GLP-1) analog in a pill and a new option for adults with type 2 diabetes who are not achieving their A1C goal with current antidiabetic treatment, added the company.
Type 2 diabetes is reportedly a global public health issue that impacts more than 28 million people in the US alone.
This US approval is based on results from the company's ten PIONEER clinical trials in 9,543 participants, which included head-to-head studies of Rybelsus vs. sitagliptin, empagliflozin and liraglutide 1.8 mg. Rybelsus reduced A1C and, as a secondary endpoint, showed reductions in body weight, revealed the company.
Rybelsus will be launched in the US beginning in the fourth quarter of 2019. Its Initial supply will come from manufacturing facilities in Denmark; however, future its supply will come from manufacturing facilities in the US, concluded the company.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Aprecia names new chief commercial officer
Insulet's Omnipod 5 integration with Abbott FreeStyle Libre 2 Plus Sensor secures CE Mark approval
Kyowa Kirin enrols first subject in phase two tivozanib eye drops (KHK4951) clinical trial
Novo Nordisk to boost manufacturing capacity with acquisition of three fill-finish sites
Breye Therapeutics commences phase 1b/2a danegaptide clinical trial
DexCom Inc breaks ground on new manufacturing facility in Ireland
VibroSense Dynamics AB secures provisional patent for chemotherapy-induced nerve damage prediction
Innovent Biologics signs collaboration agreement with Sanegene Bio USA
Japan approves GSK's filing for Arexvy vaccination for at-risk adults
Arecor Therapeutics plc extends collaboration with Eli Lilly
OptiBiotix Health partners with Ravenswood for SlimBiome distribution in Australia and New Zealand
Boehringer Ingelheim granted European approval of oral liquid medication for feline diabetes