(RTTNews) - Tuesday, Regeneron Pharmaceuticals, Inc. (REGN: News ) announced that it has received marketing authorization in the European Union for rilonacept, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes or CAPS, including Familial Cold Auto-inflammatory Syndrome or FCAS and Muckle-Wells Syndrome or MWS, in adults and children aged 12 years and above. Marketing authorization for rilonacept was granted by the committee for Medicinal Products for Human Use of the European Medicines Agency under exceptional circumstances.

Rilonacept, which is known as Arcalyst in the United States, has been prescribed to treat the majority of patients documented to have been treated for CAPS symptoms to date in the U.S. Arcalyst is the only treatment for CAPS in the U.S. 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, noted the company.

It was revealed that in the pivotal clinical development program, patients treated with rilonacept reported a greater improvement in overall symptom scores than patients treated with placebo. These improvements were sustained over time with continued rilonacept treatment. Patients reported their symptoms using a validated daily diary instrument.

These assessments represent a critical measure of effectiveness in a disease characterized by frequent, unpredictable symptom flares of variable severity and duration.
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 authorization for approval of rilonacept in the E.U. under exceptional circumstances is permissible for products for which a company can demonstrate that comprehensive data cannot be provided, for example, because of the rarity of the condition.

REGN closed Tuesday's regular trading at $17.23 up $0.03 or0.17% on the Nasdaq.

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by RTT Staff Writer

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