Green light for 77 new medicines in the EU in 2023

Written by | 11 Jan 2024 | Legislative and Regulatory

A total of seventy-seven new medicinal products were approved in Europe last year, seven of which were given the green light in December. At European level, the EMA’s key Committee on Human Medicinal Products (CHMP) makes recommendations to the European Commission which has the final say on whether a product can be sold in the EU.

The new products recommended for final approval at the EMA’s December meeting were:

 Casgevy*(exagamglogene autotemcel), an advanced therapy medicinal product (ATMP) for the treatment of transfusion dependent beta-thalassemia and severe sickle cell disease, two inherited rare diseases caused by genetic mutations that affect the production or function of haemoglobin, the protein found in red blood cells that carries oxygen around the body.

  • Skyclarys* (omaveloxolone) for the treatment of Friedreich’s ataxia, an inherited disease causing a range of symptoms that worsen over time, including difficulty walking, inability to co-ordinate movements, muscle weakness, speech problems, damage to the heart muscle and diabetes.
  • Velsipity(etrasimod), for the treatment of patients with moderate to severe ulcerative colitis, an inflammation of the large intestine causing ulceration and bleeding.
  • Dabigatran etexilate Leon Farma (dabigatran etexilate), for prevention and treatment of venous thromboembolic events (when a blood clot forms in a vein), prevention of stroke and systemic embolism (obstruction of blood vessels), and prevention and treatment of deep vein thrombosis and pulmonary embolism.
  • Ibuprofen Gen.Orph (ibuprofen), for the treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn babies less than 34 weeks of gestational age. Patent ductus arteriosus occurs when the blood vessel that allows blood to bypass the baby’s lungs fails to close after birth, causing heart and lung problems in the baby.
  • Mevlyq (eribulin), for the treatment of breast cancer and liposarcoma, a rare cancer that develops in fat tissue.
  • Pomalidomide Viatris (pomalidomide), indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, a cancer of the bone marrow.

The committee recommended extensions of indication for four medicines that are already authorised in the EU: HyQviaMetalyseVeraSeal and Zinplava.

In addition, it backed two medicines intended for use outside the EU: Arpraziquantel (arpraziquantel), a new treatment option for the estimated 50 million young children with schistosomiasis, a neglected tropical disease caused by blood flukes (trematode worms); and Fexinidazole Winthrop (fexinidazole), a medicine used to treat human African trypanosomiasis, also known as sleeping sickness.

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