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

2024-03-22

临床结果上市批准临床3期

Europe's Committee for Medicinal Products for Human Use has signed off on Novo Nordisk's one-weekly insulin for diabetes patients, in addition to providing positive opinions on Novartis' Fabhalta and Pfizer's antibiotic combo Emblaveo.

Sales are booming for Novo Nordisk’s GLP-1 treatments for diabetes and obeNovo Nordiskat doesn’t mean the Danishdiabetes has moved on from its previous generation of blood sugarNovartisors.Pfizer

Though it’s been on thNovo Nordisk a century, there are stdiabetesnces obesityade with good old insulin.

With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMinsulino 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.Awiqli icodec Type 2 diabetes

Less than three years later, it's cinsulin arNovong. 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 typFDA diabetes initiaAwiqlinsulin treatment," Martin Holst Lange, Novo’s EVP for development, said in a release.Awiqli

TAwiqliitive CHMP opinion is based on reinsulinrom six phase 3 studies of type 2 diabetes In people winsuline 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 onType 2 diabetesr Awiqlioth 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 drugsinsulin hypoglycemia Awiqli Type 1 diabetes Awiqli hypoglycemia insulin

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 cNovartisimen Emblaveo (aztreonam-avibactam) to treat a vagenetic blood disordernparoxysmal nocturnal hemoglobinuriay notched a CHMP recommendatFDA for Lytenava (bevacizumab) for the treatment of wet age-related macular degeneration (AMD).

Nogine B.V. of the NetherlandPfizera CHMP nod for Agilus (dantrEmblaveodiaztreonam-avibactame), a treatment for maliinfectionsrthermOutlook Therapeuticsng condition in which skeletal muscles are over-sLytenava (bevacizumab)harma of Ireland got awet age-related macular degeneration (AMD)AMDtricon (dopamine hydrochloride) for hypotension.

The CHMP also signed off on three biosimilars, incAgilus tdantrolene sodiumreatments from Sandoz—Wyost and Jubbomalignant hyperthermias of Amgen’s Prolia and Xgeva (denosumab). Celltrion’s biosimilar Omlyclo, whiBrePco Biopharma of Novartis’ asthma drug Xolair (omalizumab), also made the grade.hypotension

Astellas gets thumbs-up for Xtandi expansionosteoporosis Sandoz Wyost Jubbonti Amgen Omlyclo Novartis asthma Xolair omalizumab

Astellasapproval 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 authorXtandin enzalutamidein Europe by the end of May.risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC)

The FDAP also issued pXtandie opinions that would expand theAstellasfor 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.