Swedish Regulatory Authority Confirm Approval of AirFluSal Forspiro

Vectura Group plc confirms that its partner, Sandoz, has received Swedish marketing authorisation for AirFluSal Forspiro (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). 

The product was first approved in Denmark on 18 December 2013 and Germany on 13 January 2014.  The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

Sweden has approved the 50–500 µg and 50–250 µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group.  The product's safety, efficacy and equivalence have been proven in multiple clinical trials.^1,2

The receipt of the marketing authorisations in Sweden, Germany and Denmark follows the successful completion of EU decentralised procedures also including Norway for the 50–500 µg and 50–250 µg dosage forms and for the 50–500 µg dosage form Germany, Belgium, Bulgaria, Hungary, Luxembourg and Romania. Vetter will communicate as and when further market approvals are received.

Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal Forspiro by Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.

[1] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs comparator in paediatric asthma.  Submitted ERS - Reference September 2013

[2] Sandoz data on file