Novo's diabetes treatment semaglutide gets unanimous FDA backing

Novo Nordisk is celebrating the news that its diabetes drug semaglutide has won the favour of FDA experts, with one of the regulators advisory panels voting unanimously in favour of the drug’s approval.

The panel voted 16-0 in favour with one abstention, meaning that, while the regulator is not bound to the decision, it is very likely that the peptide-1 (GLP-1) analog will now be made available to patients in the US over the coming months when a final decision is given in December.

Semaglutide is set to take on Trulicity, Eli Lilly’s own treatment which was approved in the diabetes space in 2014, hoping to take a bite out of its market share which is expected reach $3.71 in 2023. Analysts expect semaglutide itself to reach $3.17 billion by the same year.

Though the final decision reached by the panellists was positive, a key issue they discussed was the association between semaglutide use and an initial worsening of diabetic retinopathy , a condition caused high blood sugar levels damaging the blood vessels in the retina which can cause blindness.  Despite data indicating this association, panellists found that this risk was offset by the drug’s benefits for reducing blood sugar.

"Semaglutide has demonstrated the potential to improve the treatment of type 2 diabetes and the positive recommendation from the Advisory Committee marks an important step towards making semaglutide available to adults with type 2 diabetes in the US. We look forward to working with the FDA as they complete their review of semaglutide," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer.