Discovery Laboratories, Inc announced that it has achieved technical success in addressing the key remaining requirements identified by the US Food and Drug Administration (FDA) to gain marketing approval of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.
Discovery Labs is completing the remaining activities and finalizing the information for its complete response to the May 2008 FDA approvable letter and now expects to submit its complete response within the next four weeks. Discovery Labs continues to believe that the FDA may designate its complete response as a class-1 resubmission, with a target review period of 60 days and potential approval of Surfaxin in 2008.
With respect to the key remaining items identified in the approvable letter and further clarified at a June 18 meeting with the FDA, achievements expected are: Discovery Labs has successfully concluded additional Surfaxin preclinical studies at a dose level requested by the FDA in both the Surfaxin biological activity test and a well-characterized RDS animal model. Discovery Labs believes that the data further confirms the comparability of Surfaxin drug product used in Discovery Labs' phase-3 clinical trials to the commercial manufacturing process for Surfaxin and will support the determination of final acceptance criteria for the Surfaxin biological activity test.
It is also expected through a close scientific collaboration with its phospholipids suppliers, Discovery Labs has now determined that the two phospholipids drug substances that are contained in Surfaxin drug product can be produced with lipid-related impurities at levels that satisfy International Conference of Harmonization (ICH) guidelines. In the next few weeks, Discovery Labs and its phospholipids suppliers expect to complete the remaining activities and finalize the information necessary to support the complete response.
The information necessary to address the balance of the items outlined in the approvable letter, as previously disclosed, is ready for inclusion in the complete response.
Prior to receiving the approvable letter, Discovery Labs had made notable progress towards gaining FDA approval of Surfaxin, including agreeing with the FDA on the form of the Surfaxin package insert and successfully concluding a pre-approval inspection of Discovery Labs' manufacturing operations. The approvable letter did not require any additional clinical trials to gain Surfaxin approval.
Based on its understanding of FDA guidelines, and in consultation with outside experts, Discovery Labs believes that the FDA may designate the Complete Response as a Class 1 resubmission, which would result in a target review period of 60 days (whereas a Class 2 resubmission would result in a 6-month target review period). If Discovery Labs' understanding of the timeline is correct, the potential approval of Surfaxin is anticipated in 2008.
Discovery Laboratories, Inc is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases.
Surfaxin, the company's lead product from its SRT pipeline, is the subject of an approvable letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants.
Aerosurf, Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubations and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine.