Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Astellas Fungal Treatment Gets QIDP Status | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

Astellas Fungal Treatment Gets QIDP Status

Could add five years of exclusivity under GAIN Act

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Astellas Pharma US, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc., has received Qualified Infectious Disease Product (QIDP) designation from the FDA for isavuconazole as a for the treatment of invasive aspergillosis. QIDP status provides priority review and a five-year extension of market exclusivity if a product receiving such a designation is approved in the U.S.. These incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act.

The possible five-year extension is in addition to the potential seven-year exclusivity based on isavuconazole’s FDA orphan drug designation for the treatment of invasive aspergillosis. In the U.S., isavuconazole also received orphan drug designation for the treatment of zygomycosis, a life-threatening invasive fungal infection (IFI) caused by emerging molds.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics