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Adalvo announces the successful Pivotal BE program for Azelastine Hydrochloride/ Fluticasone Propionate

Business
02 June 2023

Adalvo is excited to announce that we have successfully completed our Pivotal BE program for Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray.

Our product has been developed in collaboration with one of our strategic partners, based on the reference brand Dymista®. The product is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis if the use of either intranasal antihistamine or corticosteroid alone is not considered sufficient.

DYMISTA® (azelastine hydrochloride and fluticasone propionate) nasal spray demonstrated greater nasal symptom relief vs fluticasone propionate, the active ingredient in Flonase.

The INN sold approximately $237M globally in 2022, according to IQVIA.

Following these positive results, we will proceed with the dossier filing in July 2023. This significant milestone signifies our dedication to bringing proper solutions to the market and making a tangible difference to patients in need.

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At Adalvo, there are no half measures – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward.

ajish.rajan@adalvo.com – Central & Eastern Europe, Russia & CIS
jose.rendueles@adalvo.com- North Europe, APAC, MENA & Israel
margarida.neves@adalvo.com – Brazil
marta.puig@adalvo.com - LATAM (exc. Brazil) & South Europe
paulo.rodriguez@adalvo.com – Europe
supreet.sharma@adalvo.com – UK/Ireland, North America & South Africa

arni.baldursson@adalvo.com - Head of Global BD&L

Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force