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Kevzara (sarilumab)

Region

🇪🇺 EU

Active substance

sarilumab

Company

Sanofi Winthrop Industrie

Status

Authorised

Therapeutic area

Arthritis, Rheumatoid

CHMP opinion

Fri 21 Apr 2017

EU approval

Fri 23 Jun 2017

Designations

Additional monitoring

Application

EMEA/H/C/004254

ATC

L04AC14

Official record

www.ema.europa.eu

Indication

Rheumatoid arthritisKevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Polymyalgia rheumaticaKevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper. Polyarticular juvenile idiopathic arthritis Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.