FDA grants fast track designation for Theravance’s Velusetrag for idiopathic and diabetic gastroparesis

Velusetrag is an oral investigational drug in development for the treatment of patients with gastroparesis, and is currently being studied in a large, multinational Phase 2b study in patients with confirmed gastroparesis of either diabetic or idiopathic origin. 

Gastroparesis represents a significant unmet medical need with no approved treatment options for patients with idiopathic gastroparesis and only one FDA-approved product for diabetic gastroparesis.  The condition is characterized by delayed gastric emptying of food and associated with nausea, vomiting, early satiety, postprandial fullness and upper abdominal pain.

In the United States, it is estimated to affect approximately six million individuals and includes two major sub-classes: those with diabetic gastroparesis (29% of the overall gastroparesis population) and those with idiopathic gastroparesis (36%).

FDA's Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address an unmet medical need.

Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met.

Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.

Theravance Biopharma chief medical officer Brett Haumann, MD said: "We are pleased to receive Fast Track designation for the velusetrag development program in gastroparesis, given its potential to treat patients with this serious medical condition.

“Velusetrag represents a uniquely positioned asset as the only investigational drug to be examined in a study enrolling both idiopathic and diabetic gastroparesis patients. 

"The valuable development and regulatory opportunities provided to the velusetrag program by Fast Track designation will augment our efforts to bring this important therapy to patients who currently have very few effective treatment options.  We look forward to results from our Phase 2b study in mid-2017."

Velusetrag is being developed by Theravance Biopharma in collaboration with Alfa Wassermann ("Alfa Wassermann"). 

Under the terms of the agreement, Alfa Wassermann pays for the majority of the Phase 2 clinical costs and has an exclusive option to develop and commercialize velusetrag in the European Union, Russia, China, Mexico and certain other countries, while Theravance Biopharma retains full rights to velusetrag in the United States, Canada, Japan and certain other countries.