Novo Nordisk and Ardelyx Get FDA Nod; Biogen, Eisai In Late-Stage SetbackBy
Novo Nordisk gets FDA approval for an oral form of semaglutide, a drug to treat Type II diabetes, and Biogen and Eisai have late-stage setback for Alzheimer’s drug.
Novo Nordisk Receives FDA Approval for Oral Form of Diabetes Drug
The FDA has approved Novo Nordisk’s Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment, non-insulin treatments for people with Type 2 diabetes, approved for use in the US that does not need to be injected, according to information from the FDA.
Semaglutide is already approved by the FDA for injectable administration as Novo Nordisk’s Ozempic.
Rybelsus is currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
The FDA is still reviewing Novo Nordisk’s new drug application for Rybelsus for an additional indication to reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or cardiovascular death in adults with Type 2 diabetes and established cardiovascular disease. A decision is expected in the first quarter 2020.
Ardelyx Receives FDA Approval for IBS Drug Ibsrela
The FDA has approved Ardelyx’ Ibsrela (tenapanor) for the treatment of irritable bowel syndrome with constipation in adults.
Ardelyx is pursuing strategic collaborations for Ibsrela in certain territories. Ardelyx has established agreements with Kyowa Kirin Company Limited in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.
Eisai and Biogen to Discontinue Phase III Studies of Elenbecestat for Alzheimer’s
Eisai and Biogen have decided to discontinue the Phase III clinical studies of their investigational drug, elenbecestat, for treating patients with early Alzheimer’s disease.
Elenbecestat is an oral BACE (beta amyloid cleaving enzyme) inhibitor. As part of this decision, the long-term extension of the Phase II clinical trial of elenbecestat will also be discontinued. This determination does not impact the program of the anti-amyloid beta protofibril monoclonal antibody BAN2401; the Phase III trial of BAN2401 will continue.
Earlier this year (March 2019), the companies discontinued Phase III trials for another Alzheimer’s drug, aducanumab, for treating patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.