Temat:
BIOTON
Q: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
A: The Committee noted that there were differences between the active substance in Biferonex and other interferon beta-containing medicines available on the market. It therefore concluded that the use of published studies of these interferon beta-containing medicines to support the use of Biferonex was not justified and that studies on Biferonex itself were required.
The CHMP was also of the opinion that the results of the clinical study of Biferonex did not show enough evidence that the medicine was effective. Based on the information presented to the Committee, it is not clear whether this is due to the way the study was designed, the way the results were analysed, or to the medicine itself.
At that point in time, the CHMP was of the opinion that the benefits of Biferonex in the treatment of patients with relapsing-remitting multiple sclerosis did not outweigh its risks. Hence, the CHMP recommended that Biferonex be refused marketing authorisation.
Q: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Biferonex?
A: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Biferonex.
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