GSK PLC on Monday celebrated regulatory progress for two of its products in the EU.
The Brentford, West London-based pharmaceutical maker said the European Commission has accepted its application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 50 to 59 who are at increased risk of RSV disease. If approved, it would make Arexvy the first vaccine available to the population.
Arexvy is currently approved in adults aged 60 and over to prevent lower respiratory tract disease caused by RSV. GSK expects the European regulatory decision in the third quarter of this year.
RSV is a common contagious virus affecting the lungs and breathing passages. It causes around 270,000 hospitalisations and 20,000 in-hospital deaths in adults aged 60 and over in Europe each year.
Secondly, GSK said the European Commission has granted marketing authorisation for Omjjara, generically known as momelotinib, for use in disease-related splenomegaly or symptoms in adult myelofibrosis patients with moderate to severe anaemia.
Splenomegaly refers to an enlarged spleen, while myleofibrosis is a type of bone marrow cancer that disrupts the production of blood cells.
‘The challenges of living with myelofibrosis can be burdensome, and symptomatic patients can experience spleen enlargement, fatigue, night sweats and bone pain. Until now, there have been no options specifically indicated to treat these symptoms in patients who also experience anaemia. The authorisation of Omjjara brings a new treatment option with a differentiated mechanism of action to these patients in the EU,’ said Nina Mojas, GSK’s senior vice president of Oncology Global Product Strategy.
Shares in GSK rose 1.0% to 1,551.80 pence each in London on Monday morning.
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