1. Pink Sheet

Moxidectin Sponsors Credit PRV Program For Enabling River Blindness Approval

 
• By Bridget Silverman

Medicines Development for Global Health is the first nonprofit to earn a priority review voucher for bringing a neglected tropical disease therapy to US approval. Project carried on research from the Wyeth era.

Wide angle landscape view of a tropical river in rainforest jungle with rocks, trees, and blue sky on a sunny summer day
• Source: Source: Shutterstock

FDA’s approval of the river blindness drug moxidectin is a success story for advocates of priority review voucher (PRV) incentives for neglected diseases.

The June 13 approval of moxidectin, an antihelmintic drug that is widely used in veterinary formulations, to treat onchocerciasis, a parasitic disease that is widespread in sub-Saharan Africa, is “the result of a paradigm-changing approach to the development of new medicines for neglected diseases, enabled by the PRV program,” NDA sponsor Medicines Development for Global Health

More from Approvals

More from Product Reviews

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.

Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
• By Bridget Silverman

The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.