Date: 2017-09-14
Type of information: Refusal of a Market Autorisation in the EU
Product name: Xilonix® - human IgG1 monoclonal antibody specific for human interleukin-1
Compound: human IgG1 monoclonal antibody specific for human interleukin-1
Therapeutic area: Cancer - Oncology
Action mechanism: monoclonal antibody.
Company: XBiotech (USA - TX)
Disease: debilitating symptoms of advanced colorectal cancer
Latest news:
- • On September 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) re-examined the initial opinion, and confirmed the refusal of the marketing
authorisation. At the time of the initial review, the CHMP had a number of concerns. Firstly, the study did not show
clear improvements in either lean body mass or quality of life. Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care. Lastly, there were inadequate
controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials. During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine. However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine’s benefits and manufacturing controls. The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
- • On June 23, 2017, the Committee for Medicinal Products for Human Use (CHMP) announced that XBiotech has requested a reexamination of the CHMP’s May 2017 opinion. Upon receipt of the grounds of the request, the CHMP
will re-examine its opinion and issue a final recommendation.
- • On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech, intended for treating debilitating symptoms of advanced colorectal cancer. XBiotech presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life. The medicine was compared with placebo (a dummy treatment).
The CHMP noted that the study did not show clear improvements in either lean body mass or quality of life. Secondly, there was an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care. Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials. Therefore, the CHMP was of the opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
