FDA grants orphan drug status to Neuraptive Therapeutics’ NTX-001
16 Jan 2024
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Source: Pharmaceutical Technology
The NTX-001 treatment kit is intended for peripheral nerve injury repair. Credit: namtipStudio/Shutterstock.com.
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Neuraptive Therapeutics’ NTX-001, a treatment kit containing fusogen, for peripheral nerve injury repair.
The designation is a crucial step in the development of the company’s lead development product, which is poised to potentially enhance functional outcomes rapidly for patients with peripheral nerve injuries.
NTX-001 is the only surgical technology designed to prevent Wallerian degeneration by polyethylene glycol-fusing severed axons through an improved treatment sequence within a controlled nerve isolation chamber.
Neuraptive Therapeutics chief medical officer Dr Seth Schulman stated: “Receiving the orphan drug designation for NTX-001 is a testament to our commitment to advancing healthcare solutions for patients impacted by peripheral nerve injuries who today have limited options.”
The US FDA grants ODD to therapies for the treatment of rare diseases or ailments in the region.
Neuraptive Therapeutics research and development, employee value proposition and chief operating officer Evan Tzanis stated: “The granting of orphan drug designation by the FDA comes at an important time, as we prepare to meet with regulators in the coming months to seek their input on the future development work and the ultimate path to approval.
“Following this designation, Neuraptive Therapeutics plans to accelerate the development of NTX-001, aiming to bring this promising treatment to patients as soon as possible.”
The ODD comes with benefits including marketing exclusivity for seven years to approved orphan products’ sponsors, a federal tax credit for clinical research expenditures within the US and a Prescription Drug User Fee Act fee waiver.
It gives the potential to compete for grants for research from the Office of Orphan Products Development and the opportunity to obtain regulatory assistance from the US regulator.
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