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Post by Chris-C on Oct 18, 2021 13:56:53 GMT -5
It is easy to look at the FDA response and imagine all manner of nefarious intentions. Stepping back and being clear-eyed and clear-minded will be easier tomorrow. Truth is, we have more information today than on Friday, and the information leans positive despite the delay. UTHR acknowledged this in their press release, noting that the changes to the proposed label were not substantial. UTHR rolled the dice with its expensive expedited review voucher and may have shot themselves in the foot because the accelerated schedule apparently did not provide sufficient time for FDA to do a complete review. At this point, we don't know how long it will take to address the concerns nor how long FDA will take to consider the "citizen's petition", which we speculate involves FDKP and theoretical safety issues when used with Treprostinil. UTHR is speculating on approval by Summer 2022.
The interesting thing with science is that a critic with an agenda can infinitely imagine any potentially adverse occurrence at some point in the future and argue that there is risk. With FDKP, Mannkind has studies and experience demonstrating the safety of FDKP (technosphere) with insulin. Combining FDKP with treprostinil is new ground; but because it is novel and early in its evolution, there is opportunity for nefarious critics to argue that not enough safety data has been provided. For such critics, at what point is there enough data? Science seldom provides certainty, it only provides probability. That "probability decision" for drug approval is what FDA scientists are paid to deliberate. A citizen's petition devoid of compelling scientific data demonstrating significant risk is likely to fail. Sometimes, the purpose of a petition is more to create confusion, doubt and delay than to protect the public, as the FDA itself has acknowledged.
I predict approval within a timeframe as short as 6 months. (JMHO)
GLTALs
Chris C
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Post by sayhey24 on Oct 18, 2021 15:21:02 GMT -5
No need tp speculate on what the petition requests. My suspicion is the FDA looked at it, considered it and made a decision not to request additional data nor the black box. If so it should have requested the data as part of the CRL and would have added the box in the label update.
1. Refuse to approve the NDA for Tyvaso DPI in the absence of additional clinical
data from one or more adequate and well-controlled clinical investigations
demonstrating that FDKP, at the levels used in Tyvaso DPI’s dry powder
formulation, is safe and does not present undue risks of acute bronchospasm in
the intended patient populations, i.e., patients with PAH and PH-ILD, including
a statistically relevant number of patients with comorbid asthma and/or COPD;
and
2. Require Tyvaso DPI to be contraindicated in patients with chronic lung disease
such as asthma and COPD; and
3. Require the labeling of Tyvaso DPI to bear a conspicuous boxed warning
regarding:
a. the serious risk of acute bronchospasm in patients with chronic lung
diseases, such as asthma and COPD, and
Division of Dockets Management
Page 3
b. the need to conduct rigorous testing prior to initiating Tyvaso DPI to
identify comorbid chronic lung diseases, such as asthma and COPD, for
which Tyvaso DPI is contraindicated; and
4. Refuse to approve Tyvaso DPI without a REMS intended to educate HCPs
about the risk of acute bronchospasm in patients with chronic lung disease and
the need to conduct testing prior to initiating Tyvaso DPI to identify such
patients at increased risk of acute bronchospasm.
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Post by cjm18 on Oct 18, 2021 15:27:53 GMT -5
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Post by sayhey24 on Oct 18, 2021 15:31:50 GMT -5
Martine is pleased with the label, me too. I was concerned what would happen here.
“We are very pleased with the FDA’s feedback on the label, which will ultimately enable us to bring Tyvaso DPI to
thousands of patients in need,” said Martine
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Post by harryx1 on Oct 18, 2021 15:43:19 GMT -5
I still think the FDA decision is bull$&^t and smells like it too... JMHO!!!
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Post by uvula on Oct 18, 2021 16:28:55 GMT -5
If a third party person did screw up then the fda really had no choice but to delay approval. It sucks but we should be pissed at the person who is probably looking for a job and is having a much worse day than we are.
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Post by beardawg on Oct 18, 2021 16:30:27 GMT -5
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Post by harryx1 on Oct 18, 2021 16:55:15 GMT -5
If a third party person did screw up then the fda really had no choice but to delay approval. It sucks but we should be pissed at the person who is probably looking for a job and is having a much worse day than we are. Really?? You're worried about 1 person that may or may not exist but not 1000's of ill patients that could have their quality of life increased and extended??? You really amaze me but I shouldn't be surprised by your response by all the other responses you've made over the years. And if this is the only lab used and it services the 3 other FDA approved drugs currently on the market then why are those not impacted? IMO, it was just used as an excuse to have something they could blame for declining to approve Tyvaso DPI. Because if the problem doesn't affect the other 3 drugs that use that lab then why would it keep Tyvaso DPI from being approved. |
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Post by sportsrancho on Oct 18, 2021 17:25:18 GMT -5
Harry…some thoughts.
It’s not stable at room temperature ..they are citing that is the reason for the cough just like with Afrezza.
But isn’t it actually stable at room temperature, and isn’t it the users that know that that don’t refrigerate it the ones that never had a problem with the cough…
Not sure if that’s correct but that’s basically what I remember. It just seems there could be things done to improve the odds.
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Post by sweedee79 on Oct 18, 2021 17:45:37 GMT -5
If a third party person did screw up then the fda really had no choice but to delay approval. It sucks but we should be pissed at the person who is probably looking for a job and is having a much worse day than we are. Really?? You're worried about 1 person that may or may not exist but not 1000's of ill patients that could have their quality of life increased and extended??? You really amaze me but I shouldn't be surprised by your response by all the other responses you've made over the years. And if this is the only lab used and it services the 3 other FDA approved drugs currently on the market then why are those not impacted? IMO, it was just used as an excuse to have something they could blame for declining to approve Tyvaso DPI. Because if the problem doesn't affect the other 3 drugs that use that lab then why would it keep Tyvaso DPI from being approved. I believe it was an excuse as well Harry... I'm right there with you.. and my thots about lqda's hand in this.... I know some will disagree.. but I just think it's odd.. because this is exactly what lqda wanted.... Not to mention that Martine paid a lot of money to get this expedited... Something just isn't right... |
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Post by harryx1 on Oct 18, 2021 19:09:03 GMT -5
Harry…some thoughts. It’s not stable at room temperature ..they are citing that is the reason for the cough just like with Afrezza. But isn’t it actually stable at room temperature, and isn’t it the users that know that that don’t refrigerate it the ones that never had a problem with the cough… Not sure if that’s correct but that’s basically what I remember. It just seems there could be things done to improve the odds. Tyvaso doesn’t need to be refrigerated and they said the same label as Tyvaso TYVASO comes in plastic ampules packaged in a light-protective foil pouch and are good until the date shown, when stored in the unopened pouch at the temperature range indicated on the pouch. TYVASO ampules do not need to be refrigerated, and should be stored away from light. TYVASO ampules can be used until the expiration date printed on the pouch. Do not use TYVASO ampules past the expiration date printed on the pouch. TYVASO ampules should be used within 7 days after opening the foil pouch. TYVASO can be kept in the TYVASO Inhalation System medicine cup for no more than 1 day. Throw away any remaining TYVASO that is left in the medicine cup at the end of the day. |
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Post by peppy on Oct 18, 2021 19:17:10 GMT -5
Really?? You're worried about 1 person that may or may not exist but not 1000's of ill patients that could have their quality of life increased and extended??? You really amaze me but I shouldn't be surprised by your response by all the other responses you've made over the years. And if this is the only lab used and it services the 3 other FDA approved drugs currently on the market then why are those not impacted? IMO, it was just used as an excuse to have something they could blame for declining to approve Tyvaso DPI. Because if the problem doesn't affect the other 3 drugs that use that lab then why would it keep Tyvaso DPI from being approved. I believe it was an excuse as well Harry... I'm right there with you.. and my thots about lqda's hand in this....
I know some will disagree.. but I just think it's odd.. because this is exactly what lqda wanted.... Not to mention that Martine paid a lot of money to get this expedited... Something just isn't right... LQDA would get the Treprostinil from UTHR as well. Wouldn't the Treprostinil supplied to them be the same tainted Treprostinil? What am I missing? Is this over my head? |
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Post by uvula on Oct 18, 2021 19:18:03 GMT -5
If a third party person did screw up then the fda really had no choice but to delay approval. It sucks but we should be pissed at the person who is probably looking for a job and is having a much worse day than we are. Really?? You're worried about 1 person that may or may not exist but not 1000's of ill patients that could have their quality of life increased and extended??? You really amaze me but I shouldn't be surprised by your response by all the other responses you've made over the years. And if this is the only lab used and it services the 3 other FDA approved drugs currently on the market then why are those not impacted? IMO, it was just used as an excuse to have something they could blame for declining to approve Tyvaso DPI. Because if the problem doesn't affect the other 3 drugs that use that lab then why would it keep Tyvaso DPI from being approved. Harry, your response directed at me doesn't remotely match what I said at all. |
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Post by sweedee79 on Oct 18, 2021 20:20:01 GMT -5
I believe it was an excuse as well Harry... I'm right there with you.. and my thots about lqda's hand in this....
I know some will disagree.. but I just think it's odd.. because this is exactly what lqda wanted.... Not to mention that Martine paid a lot of money to get this expedited... Something just isn't right... LQDA would get the Treprostinil from UTHR as well. Wouldn't the Treprostinil supplied to them be the same tainted Treprostinil? What am I missing? Is this over my head? Well maybe they both get it from the same lab.. maybe lqda knew about this situation.. Roger Jeff's who is now at lqda was Co-CEO at UTHR.. If anything was actually tainted it would be shut down you would think.. like Harry said what about the other trep drugs that UTHR has? None of it makes any sense.. Why not give us a tentative approval til it's fixed..? . Lqda has a tentative PDUFA on Nov 7... |
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Post by peppy on Oct 19, 2021 9:58:57 GMT -5
LQDA would get the Treprostinil from UTHR as well. Wouldn't the Treprostinil supplied to them be the same tainted Treprostinil? What am I missing? Is this over my head? Well maybe they both get it from the same lab.. maybe lqda knew about this situation.. Roger Jeff's who is now at lqda was Co-CEO at UTHR.. If anything was actually tainted it would be shut down you would think.. like Harry said what about the other trep drugs that UTHR has? None of it makes any sense.. Why not give us a tentative approval til it's fixed..? . Lqda has a tentative PDUFA on Nov 7... I looked. Liquida get their Treprostinil from Sandoz and so does UTHR. SANDOZ is a Novartis division. Liquida states Sandoz their Treprostinil suppliers their website. Who manufactures treprostinil? Princeton, New Jersey, March 25, 2019 – Sandoz today announced the US availability of Treprostinil Injection , the first fully substitutable AP rated generic version of Remodulin®* (treprostinil) Injection, sold by United Therapeutics Corporation, including 180 days of marketing exclusivity for the product.Mar 26, 2019 Looks like same Treprostinil chit different day. I did not see a device for the Liquida dry powder Treprostinil. ( An injection able dry powder is made by Liquida as well.) Both you and Sports are all over Liquida, is this from stock wits? I am disappointed Martine did not have all the bases covered. |
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