Hoped-for COPD approval fades with FDA rejection
- The Food and Drug Administration has knocked back Sunovion Pharmaceuticals' hopes with a complete response letter for SUN-101/eFlow (glycopyrrolate nebulizer) for chronic obstructive pulmonary disease (COPD).
- The reason behind this rejection is unclear, although Sunovion has stated that the CRL has not requested any additional clinical studies — suggesting safety and efficacy are not issues.
- Parent company Sumitomo Dainippon Pharma has seen a slump of 3.5% in stock value on the news.
Ten months after its new drug application submission, Sunovion Pharmaceutical has received a rejection from the FDA for SUN-101/eFlow, an inhaled treatment for chronic obstructive pulmonary disease (COPD).
SUN-101/eFlow combines the long-acting muscarinic antagonist (LAMA) bronchodilator with an tailored version of Pari Pharma's eFlow closed system nebulizer. The nebulizer has been designed to deliver drugs deep into the lungs quickly and quietly.
The company press release simply stated: "Sunovion will work with the FDA to determine an appropriate path forward. We are confident in SUN-101/eFlow and are committed to bringing this innovative therapy to COPD patients in the U.S. as quickly as possible."
Around 15.7 million adults across the U.S. have been diagnosed with COPD, a serious but preventable disease that reduces the ability to perform routine activities, affects sleep, and leads to more than 120,000 premature deaths each year.
A deal late last year boosted Sunovion's COPD portfolio, when the Japanese company snagged U.S. commercialization rights for Utibron Neohaler (indacaterol/glycopyrrolate), Seebri Neohaler (glycopyrrolate) and Arcapta Neohaler (indacaterol) from Novartis.
Novartis isn't the only big pharma licensing out COPD assets – AstraZeneca signed a deal with Oxford, U.K.-based Circassia in March 2017, granting Circassia rights to two COPD drugs, Tudorza (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol fumarate). Tudorza has been on the market since 2012, and Duaklir could be launched as early as 2018.
- Sunovio Pharmaceuticals Press release
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