According to Aradigm Corporation, the company has been informed that its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE) is likely to receive a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). CHMP is scheduled to discuss the MAA at a November 2019 meeting.
Aradigm, which filed for bankruptcy in February 2019, originally submitted the MAA in March 2018 and said in January 2019 that it had submitted responses to EMA 120 day questions. In the US, where the dual release inhaled ciprofloxacin is known as Apulmiq, the FDA issued a complete response letter to Aradigm’s NDA in January 2018. In February 2019, the agency said that it still had concerns about data from Phase 3 trials of Apulmiq.
In the press release regarding the upcoming CHMP meeting, the company said, “Aradigm remains confident in the efficacy, safety and quality of Apulmiq (US) / Linhaliq (EMA).”
Read the Aradigm Corporation press release.
