FDAがインターセプトの潜在的なNASH新薬オベチコール酸のレビューを遅らせる

数日前、Intercept Pharmaceuticalsは、FDAが潜在的な最初のNASH新薬の審査決定日を延期したことを発表しました。オベチコール酸（OCA）。革新的な治療法の出現を見るのが遅かったNASH分野は、良いものと言えます。

強力で特定のファルネソールX受容体（FXR）アゴニストとして、オベチコール酸は以前にREGENERATEと呼ばれる第3相臨床試験で肯定的な結果を達成しています。試験の結果は、治療の18か月以内に、異なる用量のOCAを受けた- -治療する意思のある患者（ITT）の割合が、グレード1以上で肝線維症を改善し、 17.6％（10 mg）および23.1％（25 mg）でNASH症状の悪化はなく、この値はプラセボ群で11.9％でした。

This is currently the only NASH therapy in progress that has achieved positive results in the later clinical trials. Based on the results of this trial, Intercept submitted a new drug marketing application to the US FDA. In November last year, the FDA accepted the listing application and granted it priority review status. According to the original plan, the FDA should respond before March 26 this year.

However, in December last year, the FDA informed Intercept that it would hold an advisory board meeting on April 22 this year to discuss data on the drug. Given that this date is later than March 26, Intercept expects that the FDA response date will also be delayed. On January 15 this year, the FDA actually notified the company that it would postpone the decision date to June 26, which is a full three months behind the original date.

Intercept & #39;s announcement also states that this indicates that the FDA needs more time to review the data and complete the review.

On January 15th, Intercept CEO Dr. Mark Pruzanski remained optimistic in an interview with BioPharma Dive: & quot;I am very confident. We are ready and we will promote the successful launch of this new drug. & quot; I look forward to the final approval of this therapy, bringing the gospel to patients around the world!