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Post by mannmade on Jul 22, 2014 13:03:27 GMT -5
Grabbed this off Yahoo just now... Does this suggest a European and/or Global partner is ready to be announced in the next few weeks. I do not like spreading rumors am just looking for opinions and others with information...
Looks like possible launch in UK in 2015...
UK Medicines Information UK Medicines Information
NHS
New Drug Application for Afrezza® (inhaled insulin) for the treatment of adults with diabetes resubmitted to the US FDA
Information type: Media and commentaries
Source: Biospace Inc.
Specialities: Diabetes
Summary
A New Drug Application for Afrezza® (inhaled insulin) for type 1 and 2 diabetes has been resubmitted to the US FDA. The resubmission is based on the entire data set from the clinical development program, including the results from two recent Phase III trials.
UKMi comment
Afrezza® is currently in Phase III development in the UK and US. It is predicted for launch in the UK in 2015.
Related links:
Terms and Conditions
For feedback or enquiries relating to this service please email: medicinesresources@gstt.nhs.uk
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Post by otherottawaguy on Jul 22, 2014 14:15:16 GMT -5
www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631
uk Medicines Information Uk Medicines Information
NDO Logo
Home | Additional information is available to accredited, [registered, NHS users]
New Drugs Online Report for insulin inhaled
Information
Generic Name:
insulin inhaled
Trade Name: Afrezza
Synonym: Afresa
Entry Type: New molecular entity
Developmental Status
UK: Phase III Clinical Trials
EU: Phase III Clinical Trials
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
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
Interesting no?
Do we know any registered users on the NHS in the UK?
OOG
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Post by bion61 on Jul 23, 2014 3:26:07 GMT -5
This is just intended to warn the NHS in the UK that this is likely to be licensed in the UK and that they need to find the cash to pay for it. It indicates that it's now licensed in the US but not in Europe/UK.
Phase 3 for UK/Europe - this simply means that it's not licensed There. Yet. Nothing more should be read into it. MannKind conducted a lot of their studies in Europe.
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Post by otherottawaguy on Jul 23, 2014 12:27:28 GMT -5
Guess my main point above was to see if we had any registered user that could tell us about: - "UK launch Plans: Available only to registered users" and
- "Actual UK launch date:"
OOG
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Post by daduke38 on Jul 23, 2014 16:44:12 GMT -5
Trying to learn this site! Kind of a test post. Tired of YMB and Al Bundy is my hero! Thought I would start here
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Post by sportsrancho on Jul 23, 2014 17:20:04 GMT -5
Good to see you here. Yahoo is crazy!
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Post by liane on Jul 23, 2014 18:08:23 GMT -5
Trying to learn this site! Kind of a test post. Tired of YMB and Al Bundy is my hero! Thought I would start here Welcome aboard daduke! The board is pretty easy to follow once you get used to it. There is a help button at the top that explains anything you might want to do. |
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Post by daduke38 on Jul 23, 2014 19:35:11 GMT -5
Trying to learn this site! Kind of a test post. Tired of YMB and Al Bundy is my hero! Thought I would start here Welcome aboard daduke! The board is pretty easy to follow once you get used to it. There is a help button at the top that explains anything you might want to do. Thank you! |
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