Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what information his Department holds on the efficacy of anakinra for patients diagnosed with idiopathic recurrent pericarditis; and what the (a) target, (b) average and (c) longest time taken to approve that drug for use was in the last 12 months for which data is available.

The Medicines and Healthcare products Regulatory Agency (MHRA) does not hold information concerning the efficacy of anakinra for patients diagnosed with idiopathic recurrent pericarditis.

Kineret, containing the active substance anakinra, was approved by the European Medicines Agency (EMA) in 2002 for the treatment of rheumatoid arthritis in adults. The licence was extended to include treatment of Cryopyrin-Associated Periodic Syndromes. Anakinra is not licensed to treat idiopathic recurrent pericarditis.

The EMA is required to issue an opinion on applications for new indications within 90 days of receipt of a valid application. This period will be extended if it needs to request supplementary information from the applicant. The applicant will be requested to provide supplementary information within one month, although this may be extended to two months. The assessment of any supplementary information by EMA should be completed within 60 days. The European Commission is required to amend the marketing authorisation within two months of the EMA opinion.

The MHRA does not hold information on average and longest time for approval of variations by EMA.