Drug news

Dymista (Meda AB) is EU approved via decentralised procedure for Allergic Rhinitis

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Last updated:15th Mar 2013

Published:15th Mar 2013

Source: Pharmawand

Dymista (azelastine hydrochloride and fluticasone propionate) from Meda AB has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial Allergic Rhinitis and is now approved by the MHRA in the UK.

National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior to launch. Launches are anticipated in 2013 in several countries.

Dymista is a novel nasal formulation of azelastine and fluticasone. The efficacy and safety of Dymista has been documented in several studies with more than 4,000 patients, including a long-term safety study with more than 600 patients. Dymista has consistently showed faster and more complete symptom relief than standard treatment. Dymista has been available in the US since September 2012.

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