EUROPE – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Abbvie’s Rinvoq (upadacitinib) for the treatment of adults with active non-radiographic axial spondyloarthritis.
AbbVie’s application for the approval of Rinvoq is supported by results from the phase 3 SELECT-AXIS 2 study, for which the company disclosed top line results in 2021.
During the study the therapy met the primary endpoints, while safety data was reported with no new risks identified compared to the known safety profile.
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which will review it and issue a commission decision that will be valid in all member states of the EU, as well as Iceland, Liechtenstein, Northern Ireland and Norway.
“Patients with axSpA often experience delayed diagnosis and once they do receive one, there are limited therapies available to help control disease symptoms, such as inflammation, back pain and stiffness,” explained Neil Gallagher, vice president, development and chief medical officer at AbbVie.
“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need.“
Rinvoq is currently approved for use in the EU in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and moderate to severe atopic dermatitis.
In other news, two of AstraZeneca’s existing therapies have been recommended for treating patients with some forms of high-risk breast cancers in the European Union, in a boost to the company’s oncology portfolio, Reuters reports.
Lynparza, a cancer drug developed jointly with US –based Merck, was backed for standalone use or in combination with endocrine therapy in adults with a form of genetically mutated early-stage breast cancer.
The drug, which has received a similar recommendation in the United States in March, is a key asset for AstraZeneca.
It was recommended in patients with low-to-normal levels of a protein known as HER2 that is the target of several new therapies.
Enhertu, developed jointly with Japan’s Daiichi Sankyo, was the other drug that was endorsed by the European Medicines Agency for treating an aggressive form of breast cancer characterized by a high rate of HER2.
Also, Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) – which becomes the first and only treatment option for patients with the rare disease.
The European Commission has cleared Xenpozyme (olipudase alfa) for non-central nervous system symptoms in children and adults with types A/B and B ASMD, which is also known as Niemann-Pick disease.
In ASMD, fats build up within cells, causing them to die and disrupting tissue and organ function. Type A or neuronopathic forms of the disease involve damage to the brain, while type B mostly affects other parts of the body like the lungs, liver and spleen and type A/B is a combination of the two.
Meanwhile, Sanofi has also claimed EU approval for another enzyme replacement therapy for a rare disease – Nexviadyme (avalglucosidase alfa) – as a treatment for late-onset and infantile-onset Pompe disease. The drug was registered in the US last year as Nexviazyme, according to Pharmaphorum.
It is an updated version of Sanofi’s blockbuster Myozyme/Lumizyme (alglucosidase alfa) therapies for Pompe, but is designed to be more likely to be taken up into tissues, leading to greater effects on symptoms like lung damage.