Novo Nordisk nears EU okay for oral GLP-1 drug Rybelsus after CHMP nod

European Commission

The EMA's main advisory committee has backed approval of Novo Nordisk's oral GLP-1 agonist Rybelsus, a key pipeline drug in its type 2 diabetes franchise.

Rybelsus (semaglutide) is the first GLP-1 agonist drug that can be dosed orally, and is Novo Nordisk's third drug in the class after daily injectable Victoza (liraglutide) and weekly shot Ozempic, also based on semaglutide.

The CHMP has issued a positive opinion for the drug as a treatment for adults with insufficiently controlled type 2 diabetes, to improve glycaemic control as an adjunct to diet and exercise, "providing patients with another option to treat the disease without injections," according to the panel.

The new oral drug is viewed as a key product for Novo Nordisk as it tries to case Eli Lilly's Trulicity (dulaglutide), a once-weekly GLP-1 drug that is the market leader in the class with sales of $4.12 billion in 2019.

Lilly said last week that there was no sign yet that the recent approval and launch of Rybelsus in the US had had an impact on its drug, although it’s early days as Novo Nordisk’s drug only launched at the start of the fourth quarter of 2019.

Some analysts have predicted Rybelsus could eventually become a $5 billion product, once clinicians become accustomed to having an oral alternative to the current injectable GLP-1 drugs.

The positive opinion for Rybelsus came alongside CHMP backing for Alnylam's rare disease drug Givlaari, as well as an oral cholera vaccine – Vaxchora – developed by Emergent Biosolutions and intended for use in both adults and children.

Vaxchora has been available in the US since 2016, when it was the first vaccine to be approved by the FDA to protect against diarrhoeal disease caused by Vibrio cholerae serogroup O1, the globally dominant cause of cholera.

If approved by the EMA, Vaxchora will be the only single-dose oral vaccine indicated for active immunisation against cholera in people aged over six years. The current vaccine – Valneva’s Dukoral – is given orally in two separate doses, taken one to six weeks apart. Children under six can take it as three doses.

Other notable recommendations were Bayer's Nubeqa (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

Nubeqa was approved for a similar indication in the US last July, and will compete in the nmCRPC market with Janssen's Erleada (apalutamide) and Astellas/Pfizer's Xtandi (enzalutamide).

There were also positive opinions from the CHMP for Eli Lilly’s fast-acting mealtime insulin Liumjev (insulin lispro; formerly LY 900014) for type 1 and type 2 diabetes, a product which has also been submitted in the US and Japan but not yet approved.

Fast-acting insulins are designed to mimic the normal physiologic insulin response that occurs after meals and – if approved – Lilly's drug will compete most closely with Novo Nordisk's Fiasp (insulin aspart).

The CHMP also backed Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia, originally developed by Esperion Therapeutics and licensed in Europe by Daiichi Sankyo.

The positive opinion comes ahead of an FDA verdict on the two drugs due later this month, and if approved they would provide a new option for people who can't control their cholesterol levels effectively with statins alone.

Pfizer also got the nod for Staquis (crisaborole), a topical phosphodiesterase 4 (PDE-4) inhibitor for atopic dermatitis already sold as Eucrisa in the US since 2016.

The US drugmaker also had a positive opinion on Ruxience, its biosimilar version of Roche's MabThera/Rituxan (rituximab) anti-CD20 antibody used to treat various cancer indications and rheumatoid arthritis.