Forest Laboratories says it has replied to the US Food and Drug Administration after receiving a rejection from the agency earlier this year for the investigational chronic obstructive pulmonary disease drug Daxas.
In May, the FDA issued the firms with a complete response letter regarding the New Drug Application for Daxas (roflumilast) which was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis. In the letter, the agency asked for “certain additional information and analyses of existing data”, though no additional patient trials were requested.
Forest, which bagged the US rights to the drug from Nycomed in August 2009, now says that the FDA has "acknowledged receipt of the resubmission and considers it a complete, class 2 response". The partners are now hoping to hear from the FDA about approval in the first quarter of next year.
The initial rejection came after the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10-5 against approval of Daxas, an oral once-daily phosphodiesterase 4 enzyme inhibitor. That vote came as a surprise given that earlier the panel voted 9 to 6 that Daxas is effective as a maintenance treatment for COPD, despite FDA staff documents having described the drug's benefit as modest. The committee also voted 9-6 that the drug appeared to be safe.
The road to approval in Europe was much less bumpy and earlier this month Nycomed launched Daxas in Germany. It will hit the market in eight additional European countries and Canada by the end of this year.