Sector News

Positive opinion for Novo Nordisk’s Sogroya

May 27, 2023
Life sciences

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy.

The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older. It can also be used to treat adolescents with growth failure due to growth hormone deficiency.

The positive opinion has emerged following data from Novo Nordisk’s phase 3 ‘REAL4’ trial, which demonstrated that a once-weekly subcutaneous injection of Sogroya worked as effectively as a daily injection of Norditropin.

By the conclusion of the trial period, prepubertal children who were treated with once-weekly Sogroya had achieved similar growth as children who were treated with Norditropin.

Martin Holst Lange, executive vice president for development at Novo Nordisk, was optimistic about the verdict: “Today’s positive CHMP opinion is a step forward to reducing the impact of growth hormone deficiency for children, adolescents and their families in Europe.”

He added: “We are hopeful that Sogroya will help improve the lives of children as young as three years old by offering a simpler treatment option with fewer injections in an easy-to-use device, whilst helping them to achieve their growth targets.”

Meanwhile, the European Commission (EC) will review the CHMP’s positive opinion and a final decision on marketing authorisation is expected later in the year. If approved, Sogroya will be available across some European countries by the end of 2023.

Growth hormone deficiency is a rare disease and a treatable cause of short stature – it is thought to impact around one in 3,500 to 10,000 children.

by John Pinching


comments closed

Related News

October 1, 2023

Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts

Life sciences

After attending the annual Pulmonary Embolism Symposium last week in Austin, Texas, the analysts predicted clinical guidelines could shift toward catheter-based therapy once data from ongoing randomized trials is available.

October 1, 2023

AstraZeneca and SAS link up on AI and analytics

Life sciences

SAS – the AI and analytics company – has been selected by AstraZeneca to help boost efficiency and drive automation in the delivery of statistical analyses for clinical and post-approval submissions to regulatory authorities.

October 1, 2023

Will Big Pharma engage in Medicare price negotiations? Merck, AZ and BMS say they will

Life sciences

After the Centers for Medicare & Medicaid Services (CMS) revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines.

How can we help you?

We're easy to reach