MAA filed for Linhaliq in non-cystic fibrosis bronchiectasis
A Marketing Authorization Application (MAA) has been filed with European Medicines Agency (EMA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa).
US specialty drug firm Aradigm’s (Nasdaq: ARDM) Linhaliq, formerly known as Pulmaquin, is composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. The product is being developed under a collaboration with Spanish drugmaker Grifols (GRLS: MC).
In January this year, Aradigm had a setback on the drug’s development, when it received a Complete Response Letter (CRL) from the US Food and Drug Administration, citing concerns including clinical data, human factors validation study and product quality, causing a near 40% slump in the firm’s share price.
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