FDA Continues Clinical Hold on Insmed (INSM) ARIKACE Phase 3; More Info Needed
Tweet
Share
E-mailGet Alerts INSM Hot Sheet
Join SI Premium – FREE
Insmed Incorporated (Nasdaq: INSM) has been notified by the U.S. Food and Drug Administration (FDA) that it is continuing the clinical hold previously placed on Insmed's phase 3 clinical trial for ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.
As announced on August 1, 2011, the clinical holds placed on ARIKACE in NTM and Cystic Fibrosis (CF) patients with Pseudomonas lung infections were based on an initial review by FDA of the interim results of a long-term rat inhalation carcinogenicity study reported to the Agency by Insmed with ARIKACE. At that time, FDA requested additional information on ARIKACE and data from the rat study. Insmed submitted its complete response to this request before the end of August.
Insmed has been informed by FDA that, based on its review of the information provided to date, including the rat inhalation carcinogenicity study results, the Agency has insufficient information to assess the risks of ARIKACE in NTM patients in the planned phase 3 clinical trial. FDA is requiring that Insmed conduct a phase 2 clinical trial in adult NTM patients intended to provide proof-of-concept efficacy and safety data for ARIKACE in NTM before the Company can proceed with a phase 3 clinical trial. In addition, Insmed will also need to further revise the assessment of the rat carcinogenicity study findings in the investigator brochure.
As announced on August 1, 2011, the clinical holds placed on ARIKACE in NTM and Cystic Fibrosis (CF) patients with Pseudomonas lung infections were based on an initial review by FDA of the interim results of a long-term rat inhalation carcinogenicity study reported to the Agency by Insmed with ARIKACE. At that time, FDA requested additional information on ARIKACE and data from the rat study. Insmed submitted its complete response to this request before the end of August.
Insmed has been informed by FDA that, based on its review of the information provided to date, including the rat inhalation carcinogenicity study results, the Agency has insufficient information to assess the risks of ARIKACE in NTM patients in the planned phase 3 clinical trial. FDA is requiring that Insmed conduct a phase 2 clinical trial in adult NTM patients intended to provide proof-of-concept efficacy and safety data for ARIKACE in NTM before the Company can proceed with a phase 3 clinical trial. In addition, Insmed will also need to further revise the assessment of the rat carcinogenicity study findings in the investigator brochure.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Synaptics CFO resigns amid pending ON Semiconductor merger
- Dermata opens preorders for Tome skincare product at $178
- Robo.ai names Hao Wang of Changer.ae to its board of directors
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
