Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli

Sales are booming for Novo Nordisk’s GLP-1 treatments for diabetes and obesity. But that doesn’t mean the Danish company has moved on from its previous generation of blood sugar modulators.

Though it’s been on the market for a century, there are still advances to be made with good old insulin.

With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP), Novo has come a step closer to bringing its revolutionary Awiqli (once-weekly basal insulin icodec) to the market. The treatment has been tested successfully in both Type 1 and Type 2 diabetes patients.

“The world has never seen a weekly insulin,” Novo CEO Lars Fruergaard Jørgensen told Fierce Pharma in August of 2021.

Less than three years later, it's close to arriving. The company expects the FDA to sign off on Awiqli next month and to get a nod in Europe by the end of May. By reducing the frequency of dosing, Awiqli could improve convenience, adherence and quality of life.

“Awiqli has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment," Martin Holst Lange, Novo’s EVP for development, said in a release.

The positive CHMP opinion is based on results from six phase 3 studies of 4,000 patients. In people with Type 2 diabetes, Awiqli achieved superior blood sugar reduction and time spent within a recommended blood sugar range compared with daily basal insulin.

In those with Type 2 who have not been treated with insulin, observed rates of hypoglycemia were below one event per year with both Awiqli and the comparators. In people with Type 1 diabetes, Awiqli showed non-inferiority in reducing blood sugar but with a higher estimated rate of hypoglycemia compared with daily insulin.

CHMP says "yes" to other new drugs

Also getting a positive opinion from the CHMP was Novartis’ Fabhalta (iptacopan), a treatment for the rare genetic blood disorder paroxysmal nocturnal hemoglobinuria, which was approved by the FDA three months ago.

The CHMP further recommended Pfizer’s antibiotic combo regimen Emblaveo (aztreonam-avibactam) to treat a variety of infections. And Outlook Therapeutics of New Jersey notched a CHMP recommendation for Lytenava (bevacizumab) for the treatment of wet age-related macular degeneration (AMD).

Nogine B.V. of the Netherlands got a CHMP nod for Agilus (dantrolene sodium, hemiheptahydrate), a treatment for malignant hyperthermia, a life-threatening condition in which skeletal muscles are over-stimulated. BrePco Biopharma of Ireland got a CHMP thumbs up for pediatric use of Neoatricon (dopamine hydrochloride) for hypotension.

The CHMP also signed off on three biosimilars, including two osteoporosis treatments from Sandoz—Wyost and Jubbonti, which are copycats of Amgen’s Prolia and Xgeva (denosumab). Celltrion’s biosimilar Omlyclo, which is a knockoff of Novartis’ asthma drug Xolair (omalizumab), also made the grade.

Astellas gets thumbs-up for Xtandi expansion

Besides approval recommendations for new medicines, the CHMP signed off on Astellas’ blockbuster Xtandi (enzalutamide) as a monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.

The FDA signed off on Xtandi in the indication in November. Astellas hopes for a marketing authorization endorsement in Europe by the end of May. 

The CHMP also issued positive opinions that would expand the labels for UCB’s inflammatory treatment Bimzelx, Ipsen’s pancreatic cancer medicine Onivyde, Eli Lilly’s thyroid cancer therapy Retsevmo and Daiichi Sankyo’s cholesterol drugs Nilemdo and Nustendi.