FDA, 요격 가능성있는 NASH 신약 오 베티 콜산의 검토 지연

며칠 전, Intercept Pharmaceuticals는 FDA가 잠재적 인 최초 NASH 신약의 검토 결정 날짜를 연기했다는 발표를 발표했습니다.오 베티 콜산(OCA). 혁신적인 요법의 출현을보기에 느리게 진행된 NASH 분야는 좋은 것으로 묘사 될 수있다.

강력하고 특이적인 파네 졸 X 수용체 (FXR) 작용제로서, 오 베티 콜 산은 이전에 REGENERATE 라 불리는 3 상 임상 시험에서 긍정적 인 결과를 달성했다. 시험 결과, 치료 후 18 개월 이내에, 다른 용량의 OCA를 투여 받고 1 등급 이상 간 섬유증을 개선 한 - ~ - 치료 (ITT) 환자의 비율이 17.6 % (10 mg) 및 23.1 % (25 mg)에서 NASH 증상의 악화가 없었으며,이 값은 위약 그룹에서 11.9 %였다.

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!