Alexza completes FDA review for AZ-004 NDA Alexza Pharmaceuticals.
‘We value the FDA’s review of the 1st NDA for our novel Staccato technology and we are working to address problems raised in the entire Response Letter,’ said Thomas B. King, Alexza President and CEO.in October 2010 ‘ As reported, the FDA stated in the CRL that their principal clinical protection concern was related to data from the three Stage 1 pulmonary safety studies with AZ-004. Related StoriesMayo Clinic study analyzes asthma outcomes after patients step down daily medicinesResearchers find protein that plays crucial part in development of allergic airway inflammationResearchers compare effectiveness of mixture therapy for black patients with asthmaIn the information package, Alexza also showed that the pulmonary basic safety program in topics with asthma and COPD acquired identified individuals who may be susceptible to bronchospasm, the type of this event, how it can be handled, and that Alexza thought the risk in these sufferers could possibly be mitigated through labeling and a Risk Evaluation and Mitigation Strategy plan.The establishment of a comparative effectiveness research center may ultimately improve treatment outcomes. Nevertheless, the primary concern of some individuals is whether it will ultimately evolve right into a gatekeeper for reimbursement and/or rationing, and eventually hamper the margins and R&D attempts of innovators . The special statement, ‘U.S. ‘[T]he leaders made the dedication at a high-level achieving presided over by Liberian President Ellen Johnson Sirleaf, chair of the African Leaders Malaria Alliance , in Addis Ababa, on the sidelines of the African Union summit which opened in the Ethiopian capital Sunday,’ the news headlines service notes.