Orphan Drug Designation Application Submitted by Jaguar Health Subsidiary for Crofelemer for Short Bowel Syndrome with Intestinal Failure Accepted for Review by European Medicines Agency
The conditional marketing authorization pathway in
Jaguar to host investor webcast
Napo EU's initial focus is on pursuing the EMA's conditional marketing authorization pathway in
The evaluation process for the ODD application takes approximately 90 days from acceptance for review. Sponsors who obtain orphan designation for their drug can benefit from Scientific Advice from the EMA for clinical trials for the orphan indication and receive market exclusivity for a period of ten years once the medicine is approved for commercialization.
"We are very happy that the orphan drug designation application for crofelemer for SBS-IF is now with the EMA," stated
As announced on
Crofelemer has previously received an orphan‑drug designation in the
Crofelemer is a botanical (plant-based) drug extracted and purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest.
For more information about Jaguar, please visit https://jaguar.health. For more information about
Mytesi® (crofelemer delayed release tablets) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are available at Mytesi.com.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's expectation that it will host an investor webcast on