SurfaxinTreatment for Respiratory Distress Syndrome
Update: Surfaxin (lucinactant) Now FDA Approved - March 6, 2012
Discovery Labs Reports Surfaxin Update
Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin
WARRINGTON, Pa., Sept. 24, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. announces that it has achieved technical success in addressing the key remaining requirements identified by the U.S. 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 (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, the following achievements are expected to support Surfaxin approval:
*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.
* Through a close scientific collaboration with its phospholipid suppliers, Discovery Labs has now determined that the two phospholipid 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 phospholipid 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.
DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements relating to, among other things, the remaining steps necessary for FDA approval of Surfaxin for the prevention of RDS in premature infants and Discovery Labs' plans and expected timing to respond to the May 1, 2008 Approvable Letter.
Although Discovery Labs believes that it has made significant progress towards gaining approval of Surfaxin, gaining approval of Surfaxin involves ongoing activities, the final results of which could vary materially from Discovery Labs' expectations and the results obtained to date. Discovery Labs currently believes that it will succeed in gaining approval of its NDA for Surfaxin for the prevention of RDS in premature infants within the timeline outlined above; however, these activities and the ultimate outcomes are subject to a variety of risks, including but not limited to risks that (i) even if Discovery Labs is able to generate the additional data requested by the FDA and file its Complete Response to the Approvable letter within the timeline indicated above, the FDA may not be satisfied with the additional data and may require Discovery Labs to perform further studies or undertake other activities that are presently not contemplated by Discovery Labs,
(ii) Discovery Labs and its suppliers may encounter unanticipated problems in reducing the lipid-related drug substance impurities and such problems could delay Discovery Labs' submission of its Complete Response; (iii) the FDA may not be satisfied with Discovery Labs'
responses to other items identified in the Approvable Letter and Discovery Labs may be unable to gain approval of Surfaxin within the timeline indicated above, (iv) Discovery Labs, in the process of preparing its response to the Approvable Letter, may identify unforeseen problems that have not yet been discovered, and (v) the FDA could impose additional requirements to gain approval of Surfaxin. Any failure to provide information requested by the FDA or to adequately address the items raised in the Approvable Letter in Discovery Labs'
formal response to the Approvable Letter could significantly delay, or preclude outright, gaining approval of Surfaxin, which could potentially prevent the approval of Discovery Labs' other products.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases.
Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
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. SURFAXIN is also being developed for other neonatal and pediatric indications.
AEROSURF(tm), Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine.
Posted: September 2008
- Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome - March 6, 2012
- Discovery Labs Notified of PDUFA Date for Surfaxin - October 12, 2011
- Discovery Labs Submits Surfaxin Complete Response to FDA - September 6, 2011
- Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - February 1, 2011
- Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - January 10, 2011
- Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval - June 8, 2010
- Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval - May 19, 2010
- Discovery Labs and FDA Establish Path for Potential Surfaxin Approval - October 2, 2009
- Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval - September 11, 2009
- Discovery Labs Reports On Surfaxin End of Review Meeting With FDA - July 2, 2009
- Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter - May 12, 2009
- FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin - November 10, 2008
- Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS - October 20, 2008
- Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter - August 6, 2008
- Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter - June 19, 2008
- Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter - May 29, 2008
- Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS - May 5, 2008
- Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS - May 2, 2008
- Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA - November 16, 2007
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - November 1, 2007
- Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter - October 1, 2007
- Discovery Labs Provides Update On Progress for Surfaxin for RDS - August 2, 2007
- Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval - January 22, 2007
- Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters - September 28, 2006
- Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS - April 5, 2006
- FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin - October 21, 2005
- Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin - August 19, 2005
- Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin - August 15, 2005
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - July 29, 2005
- Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants - February 14, 2005
- Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application - June 15, 2004
- Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants - April 14, 2004