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Post by peppy on Oct 18, 2021 6:14:54 GMT -5
FDA declines to approve United-Mannkind's lung disease therapy finance.yahoo.com/news/1-u-fda-declines-approve-103603632.htmlOct 18 (Reuters) - The U.S. Food and Drug Administration has declined to approve a lung disease therapy developed by United Therapeutics and Mannkind Corp, citing an inspection issue at a third-party facility. United said on Monday the health regulator's draft label for the drug, Tyvaso DPI, includes its use as a treatment for pulmonary arterial hypertension (PAH), as well as PAH associated with interstitial lung disease (PH-ILD). In its complete response letter, the agency did not cite any deficiencies related to operations at MannKind's device manufacturing and testing facility for Tyvaso DPI. Shares of Mannkind were down 17.9% at $4.18 in premarket trading. While PAH is a type of high blood pressure that affects blood vessels in the lungs, PH-ILDs are a group of diseases that cause inflammation and scarring of the lung tissue, making it harder to breathe. (Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Ramakrishnan M.) |
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Post by peppy on Oct 18, 2021 6:58:44 GMT -5
www.kktv.com/prnewswire/2021/10/18/united-therapeutics-provides-an-update-progress-tyvaso-dpi-new-drug-application/The FDA's letter noted only a single deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance. The draft labeling for Tyvaso DPI, as revised by FDA, includes the same indications as Tyvaso® (treprostinil) Inhalation Solution for PAH and PH-ILD, to improve exercise ability, and does not contain any contraindications or a boxed warning. "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 Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier."
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Post by dh4mizzou on Oct 18, 2021 6:59:21 GMT -5
Wow. Just Wow.
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Post by curiousdoc on Oct 18, 2021 7:11:14 GMT -5
18% drop premarket seems a bit extreme given the conditions of this denial. Any idea on time it will take to rectify and reapply/approve?
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Post by goyocafe on Oct 18, 2021 7:12:37 GMT -5
18% drop premarket seems a bit extreme given the conditions of this denial. Any idea on time it will take to rectify and reapply/approve? Per the PR “by next summer or earlier”. |
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Post by peppy on Oct 18, 2021 7:28:37 GMT -5
18% drop premarket seems a bit extreme given the conditions of this denial. Any idea on time it will take to rectify and reapply/approve? "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 Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier." |
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Post by curiousdoc on Oct 18, 2021 7:37:51 GMT -5
Wonder if United's purchase of expedited review voucher can be written off?  |
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Post by neil36 on Oct 18, 2021 7:43:30 GMT -5
So if the contract between UTHR and MNKD for manufacturing is for “cost plus”, who bears the cost of all the recent hires in Danbury, while waiting for resolution?
Is that a cost that MNKD can simply pass along to UTHR?
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Post by uvula on Oct 18, 2021 7:45:01 GMT -5
I'd hate to be the person who screwed up in the third party company.
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Post by veritasfiliatemporis on Oct 18, 2021 7:49:26 GMT -5
That's why I'll buy some cheap shares, but don't chat too much...
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Post by peppy on Oct 18, 2021 7:50:24 GMT -5
I have a question.
UTHR has 5 products, three being, Treprostinil.
Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension Extended release, Treprostinil.
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension. Treprostinil injection.
TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of: Treprostinil Solution.
Here is the question. Secondary to this, deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.
Does the FDA finding effect the products UTHR has on the shelves? Hmmm?
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Post by celo on Oct 18, 2021 7:58:16 GMT -5
Does UTHR have to reformulate into DPI before Mannkind puts their molecule on to it at their facility?
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Post by boca1girl on Oct 18, 2021 7:58:33 GMT -5
So if the contract between UTHR and MNKD for manufacturing is for “cost plus”, who bears the cost of all the recent hires in Danbury, while waiting for resolution? Is that a cost that MNKD can simply pass along to UTHR? MNKD said they continue to produce product in support of product launch. Don’t know how testing of Trepostinil at a 3rd party affects “finished goods” at MNKD, but I believe that MNKD’s costs will be covered. |
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Post by boca1girl on Oct 18, 2021 8:01:00 GMT -5
Does UTHR have to reformulate into DPI before Mannkind puts their molecule on to it at their facility? MNKD creates the DPI version from what I understand. |
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Post by harryx1 on Oct 18, 2021 8:04:39 GMT -5
I have a question. UTHR has 5 products, three being, Treprostinil. Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension Extended release, Treprostinil.
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension. Treprostinil injection.
TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of: Treprostinil Solution.
Here is the question. Secondary to this, deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.Does the FDA finding effect the products UTHR has on the shelves? Hmmm? I have the same exact question. My question is does this third-party facility issue that performs analytical testing of trepostinil drug substance is used in the current nebulized Tyvaso drug product being sold to patients now? |
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