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:11/17/2016)... 17, 2016  AIC announces that it has just released a new white paper ... high-performance scale-out plus high speed data transfer storage solutions. Photo - ... ... ... Setting up a high performance computing or HPC ...
(Date:11/14/2016)... Inc. ("xG" or the "Company") (Nasdaq: XGTI, XGTIW), a ... challenging operating environments, announced its results for the third ... conference call to discuss these results on November 15, ... Key Recent Accomplishments The ... Vislink Communication Systems. The purchase is expected to close ...
(Date:6/22/2016)... 22, 2016   Acuant , the ... solutions, has partnered with RightCrowd ® ... Visitor Management, Self-Service Kiosks and Continuous Workforce ... add functional enhancements to existing physical access ... venues with an automated ID verification and ...
Breaking Biology News(10 mins):
(Date:12/7/2016)... ... December 07, 2016 , ... Huffman Engineering, Inc. , ... Wonderware Certified System Integrator Partner. Huffman Engineering is the only Nebraska-based company ... System Integrator Partner certification gives customers confidence that our engineers are fully trained ...
(Date:12/7/2016)... EDMONTON , Dec. 7, 2016 /PRNewswire/ - ... the development and commercialization of immunotherapeutic products for ... has entered into an Antibody Manufacturing Development Program ... , USA) for its oregovomab antibody product. ... its Phase IIb clinical study in ovarian cancer ...
(Date:12/7/2016)... Ontario , Dec. 7, 2016  Nordion, ... with General Atomics (GA), welcome today,s award by ... Nuclear Security Administration (NNSA) of the Phase II ... project with Nordion and the University of Missouri ... II funding will support the establishment of a ...
(Date:12/7/2016)... The report "Acrylic Processing Aid Market by Polymer Type (PVC), Fabrication Process (Extrusion, Injection Molding), ... 2026", published by MarketsandMarkets, the global market size was USD 645.4 Million in ... of CAGR of 6.2% between 2016 and 2026. ... ... , , ...
Breaking Biology Technology: