Navigation Links
OneWorld Health drug receives 'Orphan' designation from U.S. and European regulatory agencies

The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the U.S., announced today it has received Orphan Drug Designation from the two leading regulatory agencies in the world, the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), for paromomycin to treat visceral leishmaniasis (VL).

VL, also known as kala azar ("black fever"), is a fatal disease transmitted by sand flies, which spread leishmania parasites that attack internal organs. An estimated 1.5 million people worldwide are currently infected; the number of new VL cases per year is estimated at 500,000; and as many as 200,000 people die annually. More than 90 percent of VL cases occur in five countries: India, which bears the greatest disease burden, Bangladesh, Nepal, Sudan, and Brazil.

The U.S. Orphan Drug Act provides for formal protocol assistance when requested by the sponsors of drugs for rare diseases or conditions. The EMEA regulations are similar, and have the added advantage of applying to all 25 members of the European Union. Orphan Drug Designation also provides incentives such as exemption from certain registration fees, and may help pave the way for approvals in other countries.

OneWorld Health will file for approval of paromomycin in India this year where the need is greatest. It will begin the drug approval process with the FDA and/or the EMEA next year.

"We are pleased with the swift, positive responses by the FDA and EMEA agencies," said Victoria Hale, Ph.D., CEO and Founder of OneWorld Health. "By meeting the rigorous standards of either agency, we will be prepared to accelerate approvals in countries that have a critical need to treat VL."

Paromomycin is an off-patent aminoglycoside antibiotic first used in the 1960s and is still marketed in the U.S. as an oral formulation to treat intestinal parasites. The largest-ever Phase III clinical trial for visceral leishmaniasis was completed in November 2004 by OneWorld Health in collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO/TDR). The clinical trial used the injectable form of paromomycin in 667 patients in India.


'"/>

Source:Institute for OneWorld Health


Related biology news :

1. BioMed Central welcomes the new National Institutes of Health public access policy
2. Health costs soar as 60 million Americans classed as obese
3. Going To Extremes To Improve Human Health
4. Patient-choice C-section rate rises 36%: HealthGrades study
5. Grand Challenges in Global Health initiative funds Yale project
6. Health benefits of a Christmas brandy
7. Health of coral reefs detected from orbit
8. Health of Acehnese reefs in the wake of the tsunami shows human impacts more harmful
9. Healthy coral reefs of Madagascar resisting damage from climate change
10. Health Canada approves cold and flu medicine
11. Mailman School of Public Health researchers report blood DNA can be early predictor of liver cancer
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/8/2019)... ... January 07, 2019 , ... Join industry experts Julie Peacock, Client ... live webinar on Thursday, January 17, 2019 at 1pm EST. , This ... during the clinical trial process. Featured speakers will also present a case study of ...
(Date:1/7/2019)... OAKLAND, Calif. (PRWEB) , ... January 07, 2019 ... ... Artificial Intelligence (AI) and leading supplier of Graph Database technology for Knowledge Graphs ... (DBTA) as a 2019 ‘Trend-Setting’ Product . DBTA’s data and information ...
(Date:1/4/2019)... ... January 03, 2019 , ... Stay on top of ... device and food industries. Access to all webinars is free, so be sure to ... your field! Visit http://www.xtalks.com to check out our upcoming webinars, or click ...
Breaking Biology News(10 mins):
(Date:1/8/2019)... ... January 08, 2019 , ... The American Society of Gene and Cell ... a selection committee made up of industry leaders identified by the ASGCT board of ... mentored awards created to support ASGCT members designing transformative pilot studies in gene and ...
(Date:1/4/2019)... (PRWEB) , ... January 01, 2019 , ... ... first Microbiome Conference at the World Economic Forum Annual Meeting January 22-25, 2019 ... conference is invitation-only. , The World Economic Forum Annual Meeting brings together leaders ...
(Date:12/20/2018)... ... December 20, 2018 , ... New Year’s brings reflection ... changes in regulations in the European Union (EU) on the horizon, Jim Kasic, president ... , “The transition to the EU Medical Device Regulation (MDR), digital health, and big ...
(Date:12/18/2018)... Conn. (PRWEB) , ... December 17, 2018 , ... ... announced today the second cohort of emerging biosciences ventures invited to participate in ... business education to develop fundable business plans and a professional network. All startups ...
Breaking Biology Technology: