Tyvaso DPI (Treprostinil, Qhuav Powder Inhaler) raug tso tseg los ntawm US FDA!

United Therapeutics tsis ntev los no tau tshaj tawm tias US Food and Drug Administration (FDA) tau tshaj tawm tsab ntawv teb ua tiav (CRL) rau Daim Ntawv Thov Tshuaj Tshiab (NDA) rau Tyvaso DPI (inhaled.tshuaj treprostinil) qhuav hmoov inhalers. , Tsis kam lees pom zoo Tyvaso DPI: siv los kho pulmonary arterial hypertension (PAH) thiab interstitial lung disease-related pulmonary hypertension (PH-ILD) los txhim kho cov neeg mob' kev tawm dag zog.

Nws yog ib qho tsim nyog hais tias thaum United Therapeutics tau xa mus rau Tyvaso DPI NDA, nws kuj tau xa Daim Ntawv Pov Thawj Saib Xyuas Tseem Ceeb (PRV) kom nrawm rau FDA' lub voj voog tshuaj xyuas.

Hauv CRL, FDA tsuas yog tsa ib qho tsis xws luag uas tiv thaiv Tyvaso DPI kev pom zoo. Qhov tsis xws luag yog cuam tshuam nrog rau qhov teeb meem kev tshuaj xyuas pej xeem ntawm lub chaw thib peb uas ua kev tshuaj xyuas thiab kev sim ntawmtshuaj treprostinilAPIs. Tsis tas li ntawd, US FDA tsis tau hais txog qhov tsis xws luag lossis teeb meem cuam tshuam nrog Tyvaso DPI (suav nrog nws cov khoom siv cuam tshuam) tsim, kuaj thiab ntim hauv MannKind' lub Hoobkas. Tag nrho lwm qhov kev thov los ntawm lub koom haum tau raug daws lawm.

Daim ntawv qhia Tyvaso DPI tau kho los ntawm FDA suav nrog tib cov lus qhia xws li Tyvaso® (tshuaj treprostinil) Cov tshuaj nqus nqus pa rau PAH thiab PH-ILD txhawm rau txhim kho kev tawm dag zog lub cev, thiab tsis muaj contraindications lossis cov lus ceeb toom ntawm lub thawv dub.

Dr. Martine Rothblatt, Thawj Tswj Hwm thiab CEO ntawm Kev Kho Mob Ua Ke, tau hais tias:" Peb zoo siab heev rau FDA' cov lus tawm tswv yim ntawm daim ntawv lo, uas thaum kawg yuav pab kom peb nqa Tyvaso DPI rau ntau txhiab tus. cov neeg mob xav tau. Peb ntseeg tias tsab ntawv teb tag nrho suav nrog. Qhov kev thov ib leeg yuav raug daws sai sai, thiab Tyvaso DPI yuav raug pom zoo rau lub caij ntuj sov xyoo 2022 (yog tias tsis ua ntej). Cov tshuaj yuav yog ib qho kev sib tw hauv kev kho mob ntawm cov neeg mob PAH thiab PH-ILD."

Cov qauv tshuaj ntawm treprostinil

Tyvaso DPI yog lwm tiam tshiab qhuav hmoov formulation ntawm Tyvaso (tshuaj treprostinil, inhalation daws), uas yuav tsum tau muab ib txoj kev yooj yim ntawm kev tswj hwm dua li ib txwm atomized Tyvaso therapy.

Tyvaso inhalation tov yog thawj zaug pom zoo los ntawm FDA nyob rau hauv Lub Xya hli ntuj 2009 rau kev kho mob ntawm cov neeg mob pulmonary hypertension (PAH, WHO pawg 1) thiab los txhim kho lub cev muaj zog. Thaum lub Plaub Hlis Ntuj xyoo no, FDA tau pom zoo Tyvaso' qhov thib ob qhia rau kev kho mob ntawm cov neeg mob uas muaj kab mob ntsws interstitial ntsig txog pulmonary hypertension (PH-ILD; WHO Group 3) los txhim kho kev ua haujlwm.

Nws tsim nyog hais tias Tyvaso yog thawj zaug thiab tsuas yog kev pom zoo kho mob rau PH-ILD hauv Tebchaws Meskas, ua qhov tseem ceeb hauv thaj chaw PH-ILD. PH-ILD yog ib yam kab mob loj heev uas yuav ua rau muaj kev phom sij. Nyob rau hauv txoj kev tshawb fawb tseem ceeb, kev kho Tyvaso tau txhim kho tus neeg mob' kev tawm dag zog lub peev xwm.

Treprostinil yog ib qho hluavtaws prostacyclin mimic, uas feem ntau ua los ntawm ncaj qha dilating pulmonary thiab systemic arterial txaj thiab inhibiting platelet aggregation.

Combination Therapeutics tau pib ua ntau hom tshuaj rautshuaj treprostinil, suav nrog: Tyvaso (inhalation daws), Orenitram (cov ntsiav tshuaj tso tawm), thiab Remodulin (txhaj tshuaj). Tam sim no, United Therapeutics tseem tab tom txhim kho cov hmoov qhuav, Tyvaso DPI, uas yog Tyvaso' cov hmoov qhuav qhuav tom ntej.

Tyvaso DPI' Daim Ntawv Thov Tshuaj Tshiab (NDA) suav nrog cov ntaub ntawv los ntawm BREEZE txoj kev tshawb fawb. Cov txiaj ntsig tau tshaj tawm thaum Lub Ib Hlis xyoo no tau pom tias txoj kev tshawb fawb tau mus txog qhov kawg ntawm qhov kawg. Cov ntaub ntawv pov thawj kev nyab xeeb thiab kev zam ntawm PAH cov neeg mob hloov pauv ntawm Tyvaso (tshuaj treprostinil) nqus tau tshuaj rau Tyvaso DPI. Tsis tas li ntawd, cov kev tshawb fawb pharmacokinetic (PK) ua rau cov neeg ua haujlwm noj qab haus huv tau pom tias Treprostinil raug sib npaug ntawm Tyvaso DPI thiab Tyvaso inhalation daws yog sib piv.

Yog tias pom zoo, Tyvaso DPI yuav tsum ua kom muaj kev vam meej hauv kev kho mob ntawm inhaled Treprostinil, uas muab qhov zoo ntawm kev tswj xyuas yooj yim piv nrog rau Tyvaso inhaled daws.