GSK gets EU approval to sell blood cancer treatment Omijara

GSK announced on Monday that Omjjara, its brand name for momelotinib, has been granted marketing authorisation by the European Commission, giving the company permission to market the drug and make it available to patients and healthcare professionals across the EU and EEA-EFTA states of Iceland, Liechtenstein and Norway.

Omjjara is the first medicine in the continent specifically indicated for treating an enlarged spleen (known as splenomegaly) which is common with patients suffering from blood cancer myelofibrosis, specifically for those with moderate to severe anaemia.

GSK said that myelofibrosis affects an estimated one in 10,000 people in the EU, with nearly all patients likely to develop anaemia over the course of the disease.

"The challenges of living with myelofibrosis can be burdensome, and symptomatic patients can experience spleen enlargement, fatigue, night sweats and bone pain," said Nina Mojas, the senior vice president of GSK's Oncology Global Product Strategy unit.

"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."

In a separate statement, GSK also said the the European Medicines Agency has accepted its Arexvy drug, developed for the prevention of respiratory syncytial virus (RSV) disease, for regulatory review.

The application follows positive results from a Phase III study showing immune response and an "acceptable tolerability profile" in adults aged 50-59 at increased risk. GSK said it is the first company to file for regulatory approval to extend RSV vaccination to adults aged 50-59 at increased risk.