According to Avillion and AstraZeneca, the FDA has approved Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma in adults. Avillion partnered with AstraZeneca subsidiary Pearl Therapeutics on development of PT027 in 2018. In May 2022, the FDA accepted Avillion’s NDA for Airsupra. The NDA sought approval for the inhaler’s use as an asthma therapy by patients aged 4 and up; however, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval for adults only.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “With patients experiencing more than 10 million asthma exacerbations each year in the US and uncontrolled asthma expected to cost the US economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the US. Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations.”
Avillion CEO Allison Jeynes said, “We’re delighted that our clinical co-development program with AstraZeneca has been successful and that Airsupra has been approved in the US as a new treatment option for asthma patients. The Airsupra approval continues our 100% success rate facilitating clinical co-development programs with pharma companies, demonstrating the strong value our innovative model can provide to partners and the excellence and dedication of our international team. We’ve had an excellent working relationship with AstraZeneca and are excited to continue our partnership with the BATURA Phase 3b study, which is looking to continue building the evidence base of Airsupra to reduce the risk of asthma exacerbations.”
Read the AstraZeneca press release.
Read the Avillion press release.
