マドリガル・ファーマシューティカルズの掲示板の投稿コメント詳細

https://www.marketwatch.com/story/madrigal-pharmaceuticals-gets-first-fda-approval-for-drug-targeting-liver-disease-mash-bcadc9ea

Madrigal granted FDA approval for NASH therapy
マドリガル、NASH療法のFDA承認を取得

The Food and Drug Administration (FDA) on Thursday approved Madrigal Pharmaceuticals' (NASDAQ:MDGL) lead asset resmetirom as the first U.S.-approved therapy for a liver condition called nonalcoholic steatohepatitis (NASH).
米国食品医薬品局(FDA)は木曜日、マドリガル・ファーマシューティカルズ(NASDAQ:MDGL)のリードアセット・レスメチロムを、非アルコール性脂肪性肝炎(NASH)と呼ばれる肝臓疾患に対する米国初の治療法として承認した。

The approval of the once-daily oral therapy marks a landmark decision in medical history, as NASH, currently known as metabolic dysfunction-associated steatohepatitis (MASH), indicates a significantly unmet medical need with no FDA-approved therapies.
現在代謝機能障害関連脂肪性肝炎(MASH)として知られているNASHは、FDAが承認した治療法がない中で、著しくアンメットメディカルニーズを示しているため、1日1回の経口投与療法の承認は、医学史において画期的な決定となります。

以下翻訳は時数の関係で省略します。
The drug branded as REZDIFFRA will be indicated in the U.S. with diet and exercise for NASH with moderate to advanced liver fibrosis, according to the FDA's labeling information.

Madrigal (MDGL) shares are currently on hold for trading.
In September, the regulator accepted the company's marketing application for resmetirom, a thyroid hormone receptor (THR)-β selective agonist, granting March 14, 2024, as the target action date.

MDGL's Phase 3 registration program for resmetirom, which included its MAESTRO-NASH trial, backed the company's regulatory submission.

The global trial involving more than 1,700 adults with NASH and fibrosis reached both primary liver biopsy endpoints, Madrigal (MDGL) announced in December 2022.

NASH is a crowded area in biotech, where weight loss drugmakers Eli Lilly (LLY) and Novo Nordisk (NVO) (OTCPK:NONOF) are also seeking entry.

ライバル薬のことも書いていますね。