EU Endorses New Indications for 2 Rheumatic Disease Drugs

Miriam E. Tucker

Disclosures

September 20, 2013

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed expanded indications for certolizumab pegol (Cimzia, UCB Pharma SA) and anakinra (Kineret, Swedish Orphan Biovitrum AB).

Both injectable biologic drugs are currently licensed in Europe and the United States as second-line treatment for rheumatoid arthritis.

For certolizumab, the CHMP has recommended that the EMA adopt the new indication of treatment for adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to or are intolerant of nonsteroidal anti-inflammatory drugs (NSAIDs) and for adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated c-reactive protein and/or magnetic resonance imaging, who have had an inadequate response to or are intolerant of NSAIDs.

A US Food and Drug Administration (FDA) advisory committee made a similar recommendation for certolizumab in July 2013.

For anakinra, CHMP recommended marketing authorization for a new strength (100 mg/0.67 mL) solution in a prefilled syringe for a new indication: The treatment of individuals aged 8 months and older who have cryopyrin-associated periodic syndromes, including:

  • neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous, articular syndrome;

  • Muckle-Wells syndrome; and

  • familial cold autoinflammatory syndrome.

In the United States, anakinra received FDA clearance for the treatment of NOMID in January 2013.

CHMP also recommended that the new anakinra strength may be used by patients with rheumatoid arthritis in combination with methotrexate in adults with an inadequate response to methotrexate alone.

The EMA is expected to issue its decision on both medicines within 67 days.

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