Diabetes

Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.

Innogen is hoping the approval of its once-weekly GLP-1 drug Diabegone will allow it to chip away at Ozempic’s dominance in the Chinese diabetes market.

As Torrent joins Indian majors with plans to launch semaglutide in India and Brazil post patent expiry, market access topics like price and demand come up for discussion. Meanwhile, the supply chain is seen overcoming shortages

Boehringer Ingelheim’s sale of three diabetes brands in India, with the same composition as Jardiance, Jardiance Met and Glyxambi, to Torrent comes ahead of the expiry of the Indian patent for empagliflozin. A launch for other indications is also expected.

Hua Medicine’s HuaTangNing (dorzagliatin), the world’s first approved glucokinase activator, has apparently fallen short of restoring Bayer to its pre-2020 frontrunner position in China’s market for oral type 2 diabetes drugs, and the two companies' alliance is now set to be dissolved.

The agency reaffirmed support for a hemoglobin A1C endpoint for glycemic control in type 1 diabetes, but the diabetic ketoacidosis risk with sotagliflozin is so concerning that it is looking for additional benefits in patients with chronic kidney disease, a targeted subpopulation.

Indian firms Lupin and Aurobindo lay out global plans for GLP-1 agonists, as Aurobindo also updates on its biosimilar ambitions as they report results for fiscal Q2.

Some panelists favored use in T1D patients with mild chronic kidney disease, even though that was not the original indication Lexicon proposed, which was rejected in an 11-3 vote.

The Zynquista application in type 1 diabetes received a complete response letter in 2019. This time, Lexicon seeks approval for patients with T1D and chronic kidney disease. FDA review staff said making definitive conclusions about the magnitude of glucose-lowering effects in this population is difficult, and the risk of diabetic ketoacidosis remains.

CE marking for its Accu-Chek Smartguide continuous glucose monitor means Roche is on the cusp of challenging existing major players in Europe with a device whose predictive algorithms can help sufferers plan and prepare longer into the future.