Post by yossarian on Mar 24, 2015 13:17:32 GMT -5
From: www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631
This is British new drug online data base. If any one is a registered user of the database, may be able to get anticipated launch date in the UK and perhaps EU.
Information
Generic Name:
insulin inhaled
Trade Name: Afrezza
Synonym: Afresa
Entry Type: New molecular entity
Development and Regulatory status
UK: Phase III Clinical Trials
EU: Phase III Clinical Trials
US: Launched
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
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 [30].
04/02/2015 10:36:16
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 [29].
11/08/2014 21:59:13
June 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. [28]
30/06/2014 08:39:38
Apr 14: FDA has delayed the date by which it will make a decision on approval to 15 Jul [27]
07/04/2014 19:35:26
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 [26].
02/04/2014 14:11:31
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 [25].
31/03/2014 09:05:57
Oct 13: The Prescription Drug User Fee Act (PDUFA) date for Afrezza is April 13 2014 [24].
15/10/2013 14:13:40
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 [24].
15/10/2013 14:13:09
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 [21].
08/10/2012 09:08:05
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 [19].
12/08/2011 19:39:43
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 [18].
21/01/2011 08:55:19
Dec 10: FDA decision delayed by another 4 weeks until end of Jan 11 [17].
29/12/2010 14:34:37
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 [14].
20/07/2010 20:38:11
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 [9].
15/03/2010 21:50:30
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 [8].
11/01/2010 19:26:36
Jan 10: FDA due to make a decision by 16 Jan 10 [7]
08/01/2010 18:30:34
Mar 09: filed in US (4)
18/03/2009 08:49:02
US filing expected early 2009 (3)
06/02/2009 14:44:13
Ultra Rapid-Acting Inhaled Insulin Afrezza Now Available in US Pharmacies Nationwide
Twitter Summary: Sanofi + MannKind Afrezza now available in some US pharmacies; prices comparable to Novolog/Humalog, afrezzauser gives patient perspective!
Update (2/3/15): Today, Sanofi and MannKind announced the official launch of the ultra rapid-acting inhaled-insulin Afrezza. The insulin is now available at pharmacies nationwide. The diaTribe team got an exclusive call with Sanofi executives (Andrew Purcell, Vice President and Head of Sanofi’s US Diabetes Business Unit and Stefan Schwarz, Sanofi’s Head of US Marketing for Afrezza) to discuss the details of the launch and plans moving forward. Below are a few key pieces of information in regards to this official launch:
The Afrezza “Patient Savings Card” indicates that “depending on your insurance coverage,” the first prescription of Afrezza will cost $0, followed by no more than $30 for each additional refill (each refill supplies two inhalers and a month’s supply of cartridges). We are curious what insurance plans will qualify for this savings plan, but as of now details about Afrezza’s insurance coverage are not available. We have heard anecdotally that Humana insurance will likely make a decision about covering Afrezza within 3-6 months.
Before receiving a prescription for Afrezza, patients will be required to undergo a breathing test (“spirometry”) to verify their lung health (Afrezza is not approved for people with chronic lung disease, including asthma and COPD). Afrezza is also not recommended in patients who smoke or who have recently stopped smoking. Spirometry is a simple and common examination used to measure how much air the lungs can inhale and exhale, as well as how fast they can exhale. From our understanding, primary care physicians (PCPs) may be more familiar with spirometry testing than endocrinologists (as PCPs use it for patients with asthma and other breathing problems).
In our call with Sanofi management, we discussed how Afrezza compares to Exubera – the first approved inhaled insulin in the US that was later taken off the market due to issues with its design, cost, dosing complications, and long-term safety concerns. Sanofi management pointed to three main differences between Afrezza and Exubera: (i) the Afrezza device is very small and portable; (ii) the Afrezza device doesn’t require any additional cleaning or maintenance (users simply dispose of the Afrezza device after 15 days of use and replace with a new one); and (iii) Afrezza’s insulin dosing is much simpler as cartridges are labeled in subcutaneous insulin units, so no conversion factor is needed when health care providers prescribe it.
There are no concrete plans to submit Afrezza for approval outside of the US yet, though Sanofi is currently assessing the possibility of entering Afrezza into a global market.
- See more at: diatribe.org/classdevice-typetopic-area/insulin#sthash.fIwnO3Bl.dpuf
This is British new drug online data base. If any one is a registered user of the database, may be able to get anticipated launch date in the UK and perhaps EU.
Information
Generic Name:
insulin inhaled
Trade Name: Afrezza
Synonym: Afresa
Entry Type: New molecular entity
Development and Regulatory status
UK: Phase III Clinical Trials
EU: Phase III Clinical Trials
US: Launched
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
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 [30].
04/02/2015 10:36:16
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 [29].
11/08/2014 21:59:13
June 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. [28]
30/06/2014 08:39:38
Apr 14: FDA has delayed the date by which it will make a decision on approval to 15 Jul [27]
07/04/2014 19:35:26
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 [26].
02/04/2014 14:11:31
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 [25].
31/03/2014 09:05:57
Oct 13: The Prescription Drug User Fee Act (PDUFA) date for Afrezza is April 13 2014 [24].
15/10/2013 14:13:40
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 [24].
15/10/2013 14:13:09
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 [21].
08/10/2012 09:08:05
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 [19].
12/08/2011 19:39:43
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 [18].
21/01/2011 08:55:19
Dec 10: FDA decision delayed by another 4 weeks until end of Jan 11 [17].
29/12/2010 14:34:37
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 [14].
20/07/2010 20:38:11
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 [9].
15/03/2010 21:50:30
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 [8].
11/01/2010 19:26:36
Jan 10: FDA due to make a decision by 16 Jan 10 [7]
08/01/2010 18:30:34
Mar 09: filed in US (4)
18/03/2009 08:49:02
US filing expected early 2009 (3)
06/02/2009 14:44:13
Ultra Rapid-Acting Inhaled Insulin Afrezza Now Available in US Pharmacies Nationwide
Twitter Summary: Sanofi + MannKind Afrezza now available in some US pharmacies; prices comparable to Novolog/Humalog, afrezzauser gives patient perspective!
Update (2/3/15): Today, Sanofi and MannKind announced the official launch of the ultra rapid-acting inhaled-insulin Afrezza. The insulin is now available at pharmacies nationwide. The diaTribe team got an exclusive call with Sanofi executives (Andrew Purcell, Vice President and Head of Sanofi’s US Diabetes Business Unit and Stefan Schwarz, Sanofi’s Head of US Marketing for Afrezza) to discuss the details of the launch and plans moving forward. Below are a few key pieces of information in regards to this official launch:
The Afrezza “Patient Savings Card” indicates that “depending on your insurance coverage,” the first prescription of Afrezza will cost $0, followed by no more than $30 for each additional refill (each refill supplies two inhalers and a month’s supply of cartridges). We are curious what insurance plans will qualify for this savings plan, but as of now details about Afrezza’s insurance coverage are not available. We have heard anecdotally that Humana insurance will likely make a decision about covering Afrezza within 3-6 months.
Before receiving a prescription for Afrezza, patients will be required to undergo a breathing test (“spirometry”) to verify their lung health (Afrezza is not approved for people with chronic lung disease, including asthma and COPD). Afrezza is also not recommended in patients who smoke or who have recently stopped smoking. Spirometry is a simple and common examination used to measure how much air the lungs can inhale and exhale, as well as how fast they can exhale. From our understanding, primary care physicians (PCPs) may be more familiar with spirometry testing than endocrinologists (as PCPs use it for patients with asthma and other breathing problems).
In our call with Sanofi management, we discussed how Afrezza compares to Exubera – the first approved inhaled insulin in the US that was later taken off the market due to issues with its design, cost, dosing complications, and long-term safety concerns. Sanofi management pointed to three main differences between Afrezza and Exubera: (i) the Afrezza device is very small and portable; (ii) the Afrezza device doesn’t require any additional cleaning or maintenance (users simply dispose of the Afrezza device after 15 days of use and replace with a new one); and (iii) Afrezza’s insulin dosing is much simpler as cartridges are labeled in subcutaneous insulin units, so no conversion factor is needed when health care providers prescribe it.
There are no concrete plans to submit Afrezza for approval outside of the US yet, though Sanofi is currently assessing the possibility of entering Afrezza into a global market.
- See more at: diatribe.org/classdevice-typetopic-area/insulin#sthash.fIwnO3Bl.dpuf
