First Approval in Latin America for Innovative Respiratory Inhaler AirFluSal Forspiro

Vectura Group confirms that its partner Sandoz, has been granted marketing authorisation by the Mexican Health Authority (COFEPRIS) for AirFlusal Forspiro, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).

The approval in Mexico is the first in Latin America and follows the marketing authorisations in a total of eight European countries as well as in South Korea. Four European countries have already launched AirFluSal Forspiro in addition to the launch in May 2014 in South Korea.

Mexico has approved Airflusal Forspiro in the 50–100 µg, 50–250 µg and 50–500 µg dosage forms and the product will be branded IrFlosol™ Forspiro.

AirFluSal Forspiro offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone propionate (an inhaled corticosteroid) in an innovative new device. The product's safety, efficacy and equivalence have been proven in multiple clinical trials. 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's 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 recognised quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.