Princeton, NJ (PRWEB) April 03, 2014
PharmApprove, the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries, congratulates client MannKind Corporation on its successful U.S. Food and Drug Administration (FDA) Endocrine and Metabolic Advisory Committee meeting this week.
The committee voted 13 to 1 on April 1 to recommend that MannKind’s AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If approved, AFREZZA would be the first ultra rapid-acting mealtime insulin therapy available in the United States.
“PharmApprove is proud to have partnered with and supported the AFREZZA team as they presented a clear and compelling case for approval of this new insulin therapy,” said Laurie Smaldone, MD, President and Chief Scientific Officer of PharmApprove. “Our passion is working with R&D teams to prepare for key milestone regulatory events and hearings. We couldn’t be more pleased with the positive committee vote for AFREZZA.”
The FDA is not bound by the Advisory Committee's recommendation but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for AFREZZA. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of AFREZZA is April 15, 2014.
PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization, helping them win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at http://www.pharmapprove.com.