Bayer submits Marketing Authorisation Application to EMA

Bayer Healthcare has submitted a Marketing Authorisation Application to the European Medicine Agency (EMA) for radium-223 dichloride.

The drug is a treatment for castration-resistant prostate cancer (CRPC) patients with bone metastases, with the submission based on data from a Phase III ALSYMPCA (ALpharadin in Symptomatic Prostate Cancer) trial.

In the work, radium-223 substantially increased overall survival (OS) by 44 per cent, leading to a 30.5 per cent reduction in the risk of death when compared to placebo.

The median OS benefit in patients with radium-223 was 3.6 months, with this figure based on 14.9 months of overall OS with radium-223 plus the best standard of care available. This is compared with a survival time of 11.3 months with placebo treatment and the best standard of care.

However, a number of adverse effects were reported, including anemia, neutropenia and thrombocytopenia.

Other problems seen were nausea, diarrhoea and vomiting, with a total of 921 patients taking part in the trial across over 100 centres in 19 countries.

The primary endpoint of the study was overall survival, while secondary endpoints ranged from time to occurrence of skeletal related events and the impact on quality of life measures.

Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "This submission reflects our commitment to developing innovative cancer treatments for patients for whom only limited therapy options are available today.

"With its novel mode of action and the proven survival benefit, radium-223 represents an innovation in the treatment of prostate cancer and is an important example of our growing oncology portfolio."

News of Bayer's latest submission comes after UniQure's Glybera was named as the first therapy in the western world to be approved by the European Commission.

The drug is used as a treatment for people who suffer with the lipoprotein lipase deficiency metabolic disorder, with those affected by the disease unable to metabolise the fat particles carried in their blood.

Posted by Neil Clark