Regeneron’s Rilonacept Gets EU Marketing Authorisation For Rilonacept

Regeneron has received marketing authorisation in the EU for rilonacept, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Marketing authoriation for rilonacept was granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) under exceptional circumstances.

Rilonacept is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS. In the pivotal clinical development program, patients treated with rilonacept reported improvement in overall symptom scores than patients treated with placebo. These improvements were sustained over time with continued rilonacept treatment.

Rilonacept has been developed as a once-weekly injection which can be administered at home by the patient or their care giver following appropriate training.

The company said that authorisation for approval of rilonacept in the EU under exceptional circumstances is permissible for products for which a company can demonstrate that comprehensive data cannot be provided. Each year, Regeneron will need to provide the EMEA with any new information that may become available for review.

Robert Terifay, SVP, Commercial at Regeneron, said: “Rilonacept, which is known as Arcalyst in the US, has been prescribed to treat the majority of patients documented to have been treated for CAPS symptoms to date in the US Arcalyst is the only treatment for CAPS in the US that has demonstrated a significant improvement in CAPS symptoms as reported by patients in a pivotal clinical program and is approved for self-administration at home.”