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 Bayer Drug Granted Orphan Status | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

Bayer Drug Granted Orphan Status

Riociguat to treat PAH, CTEPH

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Bayer HealthCare has received from the FDA two separate orphan drug designations for its investigational, oral medication riociguat (proposed trade name Adempas), for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The Orphan Drug Designation program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

Bayer submitted an NDA for riociguat in February 2013 for two indications: (i) the treatment of PAH to improve exercise capacity, improve WHO functional class and delay clinical worsening; and (ii) the treatment of persistent/recurrent CTEPH after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.

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