News
Warmest congratulations to Wanbangde Pharmaceutical Group on receiving the U.S. FDA’s “Rare Pediatric Disease” designation for Huperzine A!
Date:
17 May,2024
Wanbande Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Wanbande Pharma") received an acknowledgment letter from the U.S. Food and Drug Administration (hereinafter referred to as "FDA") on May 1, 2024. The company’s product, huperzine A, which is used to treat hypoxic-ischemic encephalopathy (HIE) in newborns, has received FDA designation as a "Rare Pediatric Disease" (RPD) drug.
Qualification Assessment Status
The company submitted a relevant application to the FDA in March 2024 for the RPD designation of huperzine A, under application number RPD-2024-812. The FDA has now responded, confirming: "We hereby approve your request to designate huperzine A—as used in the treatment of hypoxic-ischemic encephalopathy (HIE) in newborns—a drug classified as a 'rare pediatric disease' under Section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ff(a)(4))."
Basic information about the drug
Neonatal HIE is a type of brain injury in newborns caused by oxygen deprivation and reduced cerebral blood flow. Current treatment options include supportive care, seizure management, treatment for cerebral edema, and therapeutic hypothermia, among others.
Huperzine A primarily works by inhibiting acetylcholinesterase, while also exhibiting anti-inflammatory, antioxidant, and neuroprotective effects. It is indicated for benign memory impairments, helping to enhance patients' abilities in areas such as prospective memory, associative learning, image recall, recognition of meaningless figures, and autobiographical memory. Additionally, it can improve memory deficits caused by dementia or brain-organic lesions, and is also used in the treatment of myasthenia gravis.
The Impact of Obtaining FDA "Rare Pediatric Disease" Drug Designation in the U.S.
Currently, the company’s huperzine A active pharmaceutical ingredient and huperzine A injection are already available on the market. Meanwhile, the controlled-release huperzine A tablets have entered the clinical trial phase. This time, the FDA has granted huperzine A the "Rare Pediatric Disease" designation for its treatment of hypoxic-ischemic encephalopathy in newborns, significantly accelerating the company’s global drug development strategy. The "Rare Pediatric Disease" designation, established by the FDA to encourage the development of therapies for rare, serious, and life-threatening pediatric conditions, provides critical incentives for advancing innovative treatments in this area. As a result, the company will benefit from U.S. policy support throughout product development and regulatory processes, including expert guidance from the FDA on clinical trials. If the company’s upcoming New Drug Application (NDA) for huperzine A as a treatment for neonatal HIE is approved, it will qualify for a PriorityReview Voucher (PRV), which can be used to expedite the review process of other new drug applications within the company. Alternatively, the voucher can be sold or transferred to another pharmaceutical company seeking priority review for its own innovative products, granting the recipient the exclusive right to fast-track their NDA submission with the FDA.
Related Recommendations