AfrezzaType 1 and 2 diabetes mellitus
Development and Regulatory status
May 17: Nil re: any new partnerships to further develop Afrezza. Mannkind has not yet identified all of the requirements that they need to satisfy to submit Afrezza for approval for other jurisdictions. This will require additional time, expertise and expense, including the potential need to conduct additional studies or development work for other jurisdictions beyond the work they have conducted to support the NDA for Afrezza .
Jun 16: MannKind intends to seek regional partnerships for development and commercialisation of AFREZZA in foreign jurisdictions where there are appropriate commercial opportunities. In order to commercially market AFREZZA in the US and elsewhere, MannKind also needs to develop an internal sales team and expand their marketing infrastructure, collaborate with third parties who have greater sales and marketing capabilities, and/or purchase services from a contract commercial organisation .
Jan 16: MannKind has promised to find another partner willing to market its inhaled insulin, but the company´s financial situation has led many investors to doubt whether it´ll be in business for much longer .
Jan 16: MannKind reported termination of worldwide licensing and collaboration agreement with Sanofi for the development and commercialisation of inhaled insulin. This termination will be completely effective as of July 16. Transition of the product fro Sanofi to MannKind is anticipate over three to nine months .
Feb 15: Launched in the US. Afrezza is priced at more than twice the price of Apidra ($7.54 per day, based on a daily dose of 12 units vs. $3.14 per day, respectively .
Aug 14: Sanofi and MannKind have entered into a worldwide licensing agreement for development and commercialization of Afrezza. The companies plan to launch in the US in Q1 2015 .
Jun 14: Approved by US FDA. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal. 
Apr 14: FDA has delayed the date by which it will make a decision on approval to 15 Jul 
Apr 14: An FDA advisory committee recommended approval of Afrezza voting by margins of 13-1 and 14-0 for approval in type 1 and type 2 diabetes, respectively. Committee members called for additional long-term study due to the lack of sufficient information about its potential link to lung cancer .
Mar 14: An FDA briefing states that although Afrezza has been shown to be better than placebo and non-inferior to injected insulins in lowering HbA1c levels at 24 weeks, comparative efficacy “was not compelling... because of missing data, the robustness of this analysis is an issue." It also raises serious safety concerns about risks of bronchial spasms and declining lung function .
Oct 13: The Prescription Drug User Fee Act (PDUFA) date for Afrezza is April 13 2014 .
Oct 13: Afrezza refiled in the US to improve glycaemic control in adults with type 1 or type 2 diabetes. The filing is based on the entire data set from the Afrezza clinical development programme including positive results from two recent PII trials .
Oct 12: MannKind has completed recruiting patients for two PIII studies 171 and 175 and results are expected in Q2 2013. The company plans to re-file in the US in 3Q 2013 .
Aug 11: MannKind has confirmed with the FDA the design of two studies of AFREZZA that the FDA had previously requested with the next-generation inhaler. Study 171 is an open-label study in patients with T1DM (which will have a head-to head comparison of the new inhaler vs the MedTone inhaler) and Study 174 is in patients with T2DM inadequately controlled on metformin ± other oral medication .
Jan 11: FDA issues a second complete response letter. This letter asks the company to run two news trials in T1 and T2DM to get more data on the new MedTone inhaler used to deliver the insulin formulation. They also want an update of safety information on Afrezza as well as information on proposed user training and changes to the proposed labeling of the device, blister pack, foil wrap and cartons .
Dec 10: FDA decision delayed by another 4 weeks until end of Jan 11 .
Jul 10: The FDA has accepted a resubmission for market authorization and a decision is expected by Dec 29, 2010. MannKind has submitted clinical data from a recently-completed efficacy study in patients with type 1 diabetes, updated pooled safety data and information on the comparability of the ‘Dreamboat’ delivery system vs the MedTone device used in pivotal studies .
Mar 10: The FDA has issued a complete response letter. The FDA has requested updated safety information, available clinical data that support the clinical utility of Afrezza and the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in pivotal clinical trials .
Jan 10: The FDA will miss the January 16 deadline for approval decision as it needs more time to complete its inspection of the 3rd party manufacturing facilities. The company does not know when the inspection will be complete, or when the FDA will announce its ruling on Afrezza .
Jan 10: FDA due to make a decision by 16 Jan 10 
Mar 09: filed in US (4)
US filing expected early 2009 (3)